Arrow
Spring-Wire Guide .018" (0.46 mm) diameter x 17-3/4" (45 cm) wire / Proximal End: Solid Wire .018" diameter / Distal End: Coil .018" diameter x 9 cm
10manufacturers in China registered for this device type
625catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K093050 |
| Record published | 2016-09-16 |
| Record revised | 2025-06-09 (version 30) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 | Storage environment temperature 20 to 25 °C |
| Packaging | Case of 5, case of 10, box of 25, case, case of 2, case of 25 |
| Sizes | Catheter gauge 5 to 12 Fr; length 5 to 130 cm; width 11 to 24 cm |
| Distribution end date | 2025-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN030340 | In distribution | |
| IPN034253 | In distribution | |
| IPN036980 | In distribution | |
| IPN920012 | In distribution | |
| IPN030338 | In distribution | |
| IPN034236 | In distribution | |
| IPN029791 | In distribution | |
| IPN036010 | In distribution | |
| IPN033853 | In distribution | |
| IPN927215 | In distribution | |
| IPN036907 | In distribution | |
| IPN032696 | In distribution | |
| IPN030334 | In distribution | |
| IPN000003 | Catheter Gauge 6 Fr | In distribution |
| IPN033004 | In distribution | |
| IPN038960 | In distribution | |
| IPN035362 | In distribution | |
| IPN037999 | In distribution | |
| IPN036232 | In distribution | |
| IPN037027 | In distribution | |
| IPN034280 | In distribution | |
| IPN036991 | In distribution | |
| IPN037047 | In distribution | |
| IPN000002 | Length 11 cm | In distribution |
| IPN036825 | In distribution | |
| IPN037728 | In distribution | |
| IPN032649 | In distribution | |
| IPN033171 | In distribution | |
| IPN039809 | In distribution | |
| IPN035741 | In distribution | |
| IPN036998 | In distribution | |
| IPN036981 | In distribution | |
| IPN037263 | Length 20 cm | In distribution |
| IPN034261 | In distribution | |
| IPN037073 | In distribution | |
| IPN920830 | In distribution | |
| IPN032665 | In distribution | |
| IPN927216 | In distribution | |
| IPN030064 | Catheter Gauge 12 Fr | In distribution |
| IPN036991 | In distribution | |
| IPN001119 | Length 11 cm | In distribution |
| IPN034254 | In distribution | |
| IPN036980 | In distribution | |
| IPN035838 | In distribution | |
| IPN034283 | In distribution | |
| IPN033585 | In distribution | |
| IPN037073 | In distribution | |
| IPN922464 | In distribution | |
| IPN032657 | In distribution | |
| IPN037012 | In distribution | |
| IPN035365 | In distribution | |
| IPN036322 | In distribution | |
| IPN919752 | In distribution | |
| IPN036224 | In distribution | |
| IPN036223 | In distribution | |
| IPN036347 | In distribution | |
| IPN039277 | In distribution | |
| IPN921748 | In distribution | |
| IPN034248 | In distribution | |
| IPN037070 | In distribution | |
| IPN929240 | In distribution | |
| IPN055562 | In distribution | |
| IPN036230 | In distribution | |
| IPN037009 | In distribution | |
| IPN904862 | In distribution | |
| IPN029644 | In distribution | |
| IPN036497 | In distribution | |
| IPN033003 | In distribution | |
| IPN030320 | In distribution | |
| IPN928253 | In distribution | |
| IPN034375 | In distribution | |
| IPN032961 | In distribution | |
| IPN035915 | In distribution | |
| IPN928684 | In distribution | |
| IPN036881 | In distribution | |
| IPN036653 | In distribution | |
| IPN035359 | In distribution | |
| IPN036231 | In distribution | |
| IPN033567 | In distribution | |
| IPN927207 | In distribution | |
| IPN032686 | In distribution | |
| IPN037153 | In distribution | |
| IPN038297 | In distribution | |
| IPN035908 | In distribution | |
| IPN034252 | In distribution | |
| IPN930565 | In distribution | |
| IPN036662 | In distribution | |
| IPN920109 | In distribution | |
| IPN037561 | In distribution | |
| IPN037033 | In distribution | |
| IPN922859 | In distribution | |
| IPN038976 | In distribution | |
| IPN036848 | In distribution | |
| IPN038173 | In distribution | |
| IPN037160 | In distribution | |
| IPN036995 | In distribution | |
| IPN055810 | In distribution | |
| IPN000015 | Width 11 cm | In distribution |
| IPN056387 | In distribution | |
| IPN037262 | In distribution | |
| IPN038368 | In distribution | |
| IPN920120 | In distribution | |
| IPN036478 | In distribution | |
| IPN056184 | In distribution | |
| IPN920010 | In distribution | |
| IPN034265 | In distribution | |
| IPN004664 | In distribution | |
| IPN037007 | In distribution | |
| IPN034399 | In distribution | |
| IPN034204 | In distribution | |
| IPN917277 | In distribution | |
| IPN033172 | In distribution | |
| IPN920014 | In distribution | |
| IPN925075 | In distribution | |
| IPN035364 | In distribution | |
| IPN036273 | In distribution | |
| IPN036276 | In distribution | |
| IPN035746 | In distribution | |
| IPN035835 | In distribution | |
| IPN038959 | In distribution | |
| IPN920933 | In distribution | |
| IPN033569 | In distribution | |
| IPN056573 | In distribution | |
| IPN034279 | In distribution | |
| IPN033843 | In distribution | |
| IPN930570 | In distribution | |
| IPN920122 | In distribution | |
| IPN034336 | In distribution | |
| IPN032903 | In distribution | |
| IPN037032 | In distribution | |
| IPN922854 | In distribution | |
| IPN037263 | In distribution | |
| IPN033570 | In distribution | |
| IPN032693 | In distribution | |
| IPN033169 | In distribution | |
| IPN920108 | In distribution | |
| IPN929479 | In distribution | |
| IPN036399 | In distribution | |
| IPN036835 | In distribution | |
| IPN929501 | In distribution | |
| IPN030067 | In distribution | |
| IPN036480 | In distribution | |
| IPN919755 | In distribution | |
| IPN036371 | In distribution | |
| IPN036062 | In distribution | |
| IPN037256 | In distribution | |
| IPN035363 | In distribution | |
| IPN033227 | In distribution | |
| IPN920118 | In distribution | |
| IPN919753 | In distribution | |
| IPN920119 | In distribution | |
| IPN923183 | In distribution | |
| IPN036829 | In distribution | |
| IPN036984 | In distribution | |
| IPN034327 | In distribution | |
| IPN036200 | In distribution | |
| IPN030310 | In distribution | |
| IPN034301 | In distribution | |
| IPN056388 | In distribution | |
| IPN055557 | In distribution | |
| IPN030326 | In distribution | |
| IPN036993 | In distribution | |
| IPN034287 | In distribution | |
| IPN034284 | In distribution | |
| IPN035374 | In distribution | |
| IPN033576 | In distribution | |
| IPN033241 | In distribution | |
| IPN034340 | In distribution | |
| IPN000014 | Catheter Gauge 5 Fr | In distribution |
| IPN036199 | In distribution | |
| IPN036984 | In distribution | |
| IPN038526 | In distribution | |
| IPN928206 | In distribution | |
| IPN038106 | In distribution | |
| IPN033853 | In distribution | |
| IPN036989 | In distribution | |
| IPN920420 | In distribution | |
| IPN922856 | In distribution | |
| IPN036478 | In distribution | |
| IPN055250 | In distribution | |
| IPN033170 | In distribution | |
| IPN914903 | In distribution | |
| IPN030311 | In distribution | |
| IPN920470 | In distribution | |
| IPN033570 | In distribution | |
| IPN001132 | Catheter Gauge 5 Fr | In distribution |
| IPN923936 | In distribution | |
| IPN034359 | In distribution | |
| IPN038370 | In distribution | |
| IPN030849 | Catheter Gauge 12 Fr | In distribution |
| IPNB00019 | In distribution | |
| IPN037098 | In distribution | |
| IPN037062 | In distribution | |
| IPN922916 | In distribution | |
| IPN925074 | In distribution | |
| IPN038269 | In distribution | |
| IPN930530 | In distribution | |
| IPN036982 | In distribution | |
| IPN033174 | In distribution | |
| IPN056277 | In distribution | |
| IPN036984 | In distribution | |
| IPN035911 | In distribution | |
| IPN037108 | In distribution | |
| IPN030013 | In distribution | |
| IPN034239 | In distribution | |
| IPN035644 | In distribution | |
| IPN030016 | In distribution | |
| IPN037063 | In distribution | |
| IPN920835 | In distribution | |
| IPN034374 | In distribution | |
| IPN034391 | In distribution | |
| IPN930531 | In distribution | |
| IPN034245 | In distribution | |
| IPN037098 | In distribution | |
| IPN929230 | In distribution | |
| IPN920107 | In distribution | |
| IPN925078 | In distribution | |
| IPN922858 | In distribution | |
| IPN034269 | In distribution | |
| IPN032607 | In distribution | |
| IPN034319 | In distribution | |
| IPN925080 | In distribution | |
| IPN030722 | In distribution | |
| IPN038978 | In distribution | |
| IPN032653 | Length 20 cm | In distribution |
| IPN036999 | In distribution | |
| IPN037423 | In distribution | |
| IPN034274 | In distribution | |
| IPN904848 | In distribution | |
| IPN920876 | In distribution | |
| IPN922857 | In distribution | |
| IPN037000 | In distribution | |
| IPN034350 | In distribution | |
| IPN036226 | In distribution | |
| IPN929926 | In distribution | |
| IPN035361 | In distribution | |
| IPN917275 | In distribution | |
| IPN927425 | In distribution | |
| IPN037043 | In distribution | |
| IPN033848 | In distribution | |
| IPN037160 | In distribution | |
| IPN038611 | In distribution | |
| IPN920873 | In distribution | |
| IPN032882 | In distribution | |
| IPN037737 | In distribution | |
| IPN037023 | In distribution | |
| IPN029798 | In distribution | |
| IPN037387 | In distribution | |
| IPN925076 | In distribution | |
| IPN037132 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
| INT, FirstWire | Shanghai Kindly Medical Instruments Co., Ltd. | 65 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241784 | 2024-09-18 |
Recalls Naming This Product
34 recalls name this product by its own identifiers, the UDI on its label or 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 | 2026-04-21 | Class I | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-bas | 310,606 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | 85 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 675 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | UDI-DI | 2026-03-11 | Class II | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured | 115 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2024-07-26 | Class II | Nonconforming Material/Component | Reports have been received regarding open seals on the packaging. | 14,845 kits | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2024-02-12 | Class I | Process control | Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. Th | 1,160,470 devices | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-12-12 | Class II | Labeling Change Control | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit | 80 eaches | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2018-04-11 | Class II | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. | 416,055 total products | 2020-05-15 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-12-22 | Class II | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. | 2020-05-27 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 930 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 50,263 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 24,192 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 2491 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 570 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-10-26 | Class II | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. | 6358 | 2019-12-10 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2017-05-09 | Class II | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. | 27, 485 distributed in the U.S, 4,371 distributed Internatio | 2018-09-17 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-08-08 | Class II | Process control | Shipping carton labeling error. | 690 kits | 2017-08-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-08-08 | Class II | Process control | Shipping carton labeling error. | 690 kits | 2017-08-22 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-06-02 | Class II | Labeling mix-ups | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. | 50 units in total | 2017-08-21 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2016-06-02 | Class II | Labeling mix-ups | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. | 50 units in total | 2017-08-21 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 361,640 | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 800 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 100 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 9,230 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 156,220 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 8,560 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-10-29 | Not classified | Other | Sterility may be compromised. | 16,580 units | 2012-09-29 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-07-29 | Not classified | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle | 9 | 2012-07-05 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2010-07-29 | Not classified | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle | 19 | 2012-07-05 |
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.