Arrow
Spring-Wire Guide for use with Standard 30 cc and 40 cc Intra-Aortic Balloon Catheters
1manufacturer
224catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DSP |
| Device type | System, Balloon, Intra-Aortic And Control |
| Device class | Class 2 |
| Regulation | 21 CFR 870.3535 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K060309 |
| Record published | 2015-10-16 |
| Record revised | 2025-10-13 (version 22) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight o |
| Packaging | Box of 5, box, case of 5, case, case of 4 |
| Sizes | Total volume 30 to 50 ml; catheter gauge 7 to 9 Fr; length 58 to 86 in; length 4.5 m; length 15 ft; length 175 cm; outer diameter 0.025 to 0.03 in; pressure 2000 psi |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN000355 | In distribution | ||
| IPN928122 | In distribution | ||
| IPN000323 | In distribution | ||
| IPN000273 | Length 86 in | In distribution | |
| IPN000213 | In distribution | ||
| IPN915328 | In distribution | ||
| IPN919187 | Length 86 in | In distribution | |
| IPN000234 | Length 15 ft | In distribution | |
| IPN915325 | Total Volume 40 ml | In distribution | |
| IPN000271 | Length 58 in | In distribution | |
| IPN915852 | In distribution | ||
| IPN038101 | Catheter Gauge 8 Fr | In distribution | |
| IPN000262 | Total Volume 30 ml | In distribution | |
| IPN915320 | Total Volume 40 ml | In distribution | |
| IPN000318 | In distribution | ||
| IPN927606 | In distribution | ||
| IPN000315 | In distribution | ||
| IPN928034 | In distribution | ||
| IPN001095 | In distribution | ||
| IPN000254 | Total Volume 40 ml | In distribution | |
| IPN000307 | In distribution | ||
| IPN000329 | In distribution | ||
| IPN915319 | Catheter Gauge 8 Fr | In distribution | |
| IPN000231 | 10 | In distribution | |
| IPN001074 | Length 4.5 m | In distribution | |
| IPN001072 | Length 4.5 m | In distribution | |
| IPN001076 | In distribution | ||
| IPN917287 | In distribution | ||
| IPN000327 | In distribution | ||
| IPN927434 | In distribution | ||
| IPN000212 | In distribution | ||
| IPN927610 | In distribution | ||
| IPN931279 | In distribution | ||
| IPN000320 | In distribution | ||
| IPN928036 | In distribution | ||
| IPN039780 | In distribution | ||
| IPN039794 | In distribution | ||
| IPN000313 | In distribution | ||
| IPN917285 | In distribution | ||
| IPN038075 | Catheter Gauge 7.5 Fr | In distribution | |
| IPN039787 | In distribution | ||
| IPN915865 | In distribution | ||
| IPN039791 | In distribution | ||
| IPN000203 | In distribution | ||
| IPN039783 | In distribution | ||
| IPN915327 | In distribution | ||
| IPN917288 | In distribution | ||
| IPN928123 | In distribution | ||
| IPN000284 | In distribution | ||
| IPN001071 | Length 4.5 m | In distribution | |
| IPN000263 | Total Volume 40 ml | In distribution | |
| IPN927616 | In distribution | ||
| IPN039788 | In distribution | ||
| IPN001107 | In distribution | ||
| IPN000250 | Total Volume 30 ml | In distribution | |
| IPN915872 | In distribution | ||
| IPN000216 | In distribution | ||
| IPN001101 | In distribution | ||
| IPN927621 | In distribution | ||
| IPN038074 | Catheter Gauge 7.5 Fr | In distribution | |
| IPN915324 | Total Volume 30 ml | In distribution | |
| IPN039786 | In distribution | ||
| IPN039790 | In distribution | ||
| IPN927436 | In distribution | ||
| IPN038102 | Catheter Gauge 8 Fr | In distribution | |
| IPN039793 | In distribution | ||
| IPN928120 | In distribution | ||
| IPN927598 | In distribution | ||
| IPN927608 | 10 | In distribution | |
| IPN915323 | Total Volume 50 ml | In distribution | |
| IPN000209 | In distribution | ||
| IPN928840 | In distribution | ||
| IPN001113 | In distribution | ||
| IPN927601 | In distribution | ||
| IPN927600 | In distribution | ||
| IPN000302 | In distribution | ||
| IPN919007 | In distribution | ||
| IPN914073 | Catheter Gauge 8 Fr | In distribution | |
| IPN001092 | In distribution | ||
| IPN000220 | Length 175 cm | In distribution | |
| IPN000233 | Length 15 ft | In distribution | |
| IPN928839 | In distribution | ||
| IPN038645 | In distribution | ||
| IPN039782 | In distribution | ||
| IPN000332 | In distribution | ||
| IPN915849 | In distribution | ||
| IPN000333 | In distribution | ||
| IPN001064 | In distribution | ||
| IPN000336 | In distribution | ||
| IPN915870 | In distribution | ||
| IPN001086 | In distribution | ||
| IPN001079 | In distribution | ||
| IPN000324 | In distribution | ||
| IPN927609 | In distribution | ||
| IPN915855 | In distribution | ||
| IPN919008 | In distribution | ||
| IPN000316 | In distribution | ||
| IPN927618 | In distribution | ||
| IPN927599 | In distribution | ||
| IPN928121 | In distribution | ||
| IPN000354 | In distribution | ||
| IPN928038 | In distribution | ||
| IPN000266 | Pressure 2000 psi | In distribution | |
| IPN914075 | In distribution | ||
| IPN039785 | In distribution | ||
| IPN000255 | Total Volume 40 ml | In distribution | |
| IPN000274 | Length 86 in | In distribution | |
| IPN927612 | In distribution | ||
| IPN927619 | In distribution | ||
| IPN039784 | In distribution | ||
| IPN039792 | In distribution | ||
| IPN000334 | In distribution | ||
| IPN000325 | In distribution | ||
| IPN000206 | In distribution | ||
| IPN919189 | Length 86 in | In distribution | |
| IPN927614 | In distribution | ||
| IPN000218 | In distribution | ||
| IPN000312 | In distribution | ||
| IPN000308 | In distribution | ||
| IPN000201 | In distribution | ||
| IPN039777 | In distribution | ||
| IPN927437 | In distribution | ||
| IPN000310 | In distribution | ||
| IPN915879 | In distribution | ||
| IPN000211 | In distribution | ||
| IPN000319 | In distribution | ||
| IPN000252 | Total Volume 30 ml | In distribution | |
| IPN929209 | In distribution | ||
| IPN000326 | In distribution | ||
| IPN000356 | In distribution | ||
| IPN915844 | In distribution | ||
| IPN001067 | In distribution | ||
| IPN927613 | In distribution | ||
| IPN927432 | In distribution | ||
| IPN915321 | Total Volume 30 ml | In distribution | |
| IPN000257 | Total Volume 30 ml | In distribution | |
| IPN000283 | In distribution | ||
| IPN000207 | In distribution | ||
| IPN000322 | In distribution | ||
| IPN928124 | In distribution | ||
| IPN000251 | Total Volume 40 ml | In distribution | |
| IPN038266 | In distribution | ||
| IPN000306 | In distribution | ||
| IPN039789 | In distribution | ||
| IPN929208 | In distribution | ||
| IPN000202 | In distribution | ||
| IPN000223 | In distribution | ||
| IPN000304 | In distribution | ||
| IPN914077 | In distribution | ||
| IPN915861 | In distribution | ||
| IPN000205 | In distribution | ||
| IPN000221 | In distribution | ||
| IPN038264 | In distribution | ||
| IPN919191 | Length 86 in | In distribution | |
| IPN927607 | In distribution | ||
| IPN000282 | In distribution | ||
| IPN929283 | In distribution | ||
| IPN916138 | Catheter Gauge 8 Fr | In distribution | |
| IPN039778 | In distribution | ||
| IPN915863 | In distribution | ||
| IPN000272 | Length 86 in | In distribution | |
| IPN927602 | In distribution | ||
| IPN039781 | In distribution | ||
| IPN038077 | Catheter Gauge 8 Fr | In distribution | |
| IPN000235 | In distribution | ||
| IPN915871 | In distribution | ||
| IPN927603 | In distribution | ||
| IPN000321 | In distribution | ||
| IPN000261 | Total Volume 50 ml | In distribution | |
| IPN931250 | In distribution | ||
| IPN000279 | In distribution | ||
| IPN000335 | In distribution | ||
| IPN000305 | In distribution | ||
| IPN000219 | Outer Diameter 0.03 in | In distribution | |
| IPN915322 | Total Volume 40 ml | In distribution | |
| IPN927611 | In distribution | ||
| IPN927617 | In distribution | ||
| IPN000317 | In distribution | ||
| IPN919009 | In distribution | ||
| IPN927615 | In distribution | ||
| IPN000204 | In distribution | ||
| IPN917286 | In distribution | ||
| IPN001112 | In distribution | ||
| IPN001096 | In distribution | ||
| IPN000311 | In distribution | ||
| IPN927604 | In distribution | ||
| IPN001094 | In distribution | ||
| IPN000260 | Total Volume 40 ml | In distribution | |
| IPN929210 | In distribution | ||
| IPN000314 | In distribution | ||
| IPN001073 | Length 4.5 m | In distribution | |
| IPN000253 | Total Volume 30 ml | In distribution | |
| IPN000270 | Length 86 in | In distribution | |
| IPN000309 | In distribution | ||
| IPN000224 | In distribution | ||
| IPN038076 | Catheter Gauge 7 Fr | In distribution | |
| IPN000267 | In distribution | ||
| IPN000277 | In distribution | ||
| IPN927620 | In distribution | ||
| IPN000215 | In distribution | ||
| IPN914076 | In distribution | ||
| IPN000328 | In distribution | ||
| IPN919190 | Length 86 in | In distribution | |
| IPN039779 | In distribution | ||
| IPN038265 | In distribution | ||
| IPN915326 | In distribution | ||
| IPN914074 | Catheter Gauge 8 Fr | In distribution | |
| IPN919188 | Length 58 in | In distribution | |
| IPN000236 | In distribution | ||
| IPN000214 | In distribution | ||
| IPN000331 | In distribution | ||
| IPN000225 | In distribution | ||
| IPN000264 | In distribution | ||
| IPN915858 | In distribution | ||
| IPN915317 | Catheter Gauge 8 Fr | In distribution | |
| IPN915878 | In distribution | ||
| IPN000249 | In distribution | ||
| IPN915854 | In distribution | ||
| IPN914078 | Catheter Gauge 9 Fr | In distribution | |
| IPN915318 | Total Volume 30 ml | In distribution | |
| IPN000210 | In distribution | ||
| IPN927430 | In distribution | ||
| IPN000330 | In distribution | ||
| IPN000265 | In distribution |
Same Product Code
Showing 12 of 268. All products under System, Balloon, Intra-Aortic And Control
Recalls Naming This Product
59 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2024-04-29 | Class I | Nonconforming Material/Component | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely infla | 7939 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2024-04-29 | Class I | Nonconforming Material/Component | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely infla | 44,807 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2024-04-29 | Class I | Nonconforming Material/Component | Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely infla | 3138 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1394 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 6 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 12 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 2678 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 88 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 81 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1 unit | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 29 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1 unit | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 4 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 39 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 112 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1 unit | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 48 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | ||
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 127 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 4 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 15 units | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1 unit | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2022-10-17 | Class I | Pending | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. | 1 unit | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2020-05-20 | Class I | Component design/selection | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of mo | 2123 total | 2023-01-07 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-02-10 | Class I | Process control | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. | 13,405 US and 33,735 OUS in total | 2021-05-12 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2012-11-27 | Class II | Process control | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. | 188 units | 2015-06-02 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2012-11-27 | Class II | Process control | Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter. | 637 units | 2015-06-02 |
Showing 40 of 59.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.