Arrow
Arrow-Clark(TM) VectorFlow(TM) Retrograde Hemodialysis Catheterization Set with Arrow Simplicity(R) Long-Term Access. Catheter Length, Tip to Cuff: 23 cm
2manufacturers in China registered for this device type
406catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | MSD |
| Device type | Catheter, Hemodialysis, Implanted |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5540 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K141051 |
| Record published | 2016-09-16 |
| Record revised | 2025-04-07 (version 21) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
| Packaging | Box, case, multipack, mpg |
| Sizes | Length 19 to 56 cm; catheter gauge 15 Fr |
| Distribution end date | 2025-07-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN001387 | In distribution | |
| IPN033029 | Catheter Gauge 15 Fr | In distribution |
| IPN033105 | Length 23 cm | In distribution |
| IPN032574 | Length 31 cm | In distribution |
| IPN055261 | In distribution | |
| IPN914732 | In distribution | |
| CS-15232-VF | In distribution | |
| IPN001369 | In distribution | |
| IPN033043 | Catheter Gauge 15 Fr | In distribution |
| IPN920484 | In distribution | |
| IPN032576 | Catheter Gauge 15 Fr | In distribution |
| IPN035691 | Catheter Gauge 15 Fr | In distribution |
| IPN033040 | Catheter Gauge 15 Fr | In distribution |
| IPN033037 | Catheter Gauge 15 Fr | In distribution |
| IPN001172 | In distribution | |
| IPN033104 | Length 19 cm | In distribution |
| IPN001402 | In distribution | |
| IPN001310 | In distribution | |
| IPN920782 | In distribution | |
| IPN001385 | In distribution | |
| CS-15552-VSP | In distribution | |
| ACS-15192-VFI | In distribution | |
| IPN055267 | In distribution | |
| IPN033026 | Catheter Gauge 15 Fr | In distribution |
| IPN920518 | In distribution | |
| IPN920783 | In distribution | |
| IPN032555 | Catheter Gauge 15 Fr | In distribution |
| IPN001353 | In distribution | |
| IPN033038 | Length 27 cm | In distribution |
| IPN032584 | Catheter Gauge 15 Fr | In distribution |
| IPN001393 | In distribution | |
| IPN920517 | In distribution | |
| IPN033107 | Catheter Gauge 15 Fr | In distribution |
| IPN032586 | Length 50 cm | In distribution |
| CS-15192-VFE | In distribution | |
| IPN055257 | In distribution | |
| IPN001180 | In distribution | |
| CS-15312-VFE | In distribution | |
| IPN001355 | In distribution | |
| IPN001379 | In distribution | |
| IPN035665 | Catheter Gauge 15 Fr | In distribution |
| IPN001370 | In distribution | |
| ACS-15232-VFI | In distribution | |
| IPN920481 | In distribution | |
| IPN001384 | In distribution | |
| IPN033060 | Length 31 cm | In distribution |
| IPN035677 | Length 27 cm | In distribution |
| IPN033030 | Catheter Gauge 15 Fr | In distribution |
| IPN920139 | In distribution | |
| IPN033053 | Catheter Gauge 15 Fr | In distribution |
| IPN033117 | Catheter Gauge 15 Fr | In distribution |
| IPN035666 | Catheter Gauge 15 Fr | In distribution |
| IPN033115 | Catheter Gauge 15 Fr | In distribution |
| IPN001396 | In distribution | |
| IPN914827 | In distribution | |
| CSD-15242-SP | Catheter Gauge 15.0 Fr | In distribution |
| CS-15312-VF | In distribution | |
| IPN035652 | Catheter Gauge 15 Fr | In distribution |
| IPN001364 | In distribution | |
| IPN001183 | In distribution | |
| IPN032556 | Catheter Gauge 15 Fr | In distribution |
| IPN001388 | In distribution | |
| IPN033103 | Length 19 cm | In distribution |
| IPN001306 | In distribution | |
| IPN001383 | In distribution | |
| IPN001305 | In distribution | |
| IPN001403 | In distribution | |
| CS-15192-SFXM | In distribution | |
| IPN001358 | In distribution | |
| IPN055264 | Length 19 cm | In distribution |
| IPN920494 | In distribution | |
| IPN920785 | In distribution | |
| IPN032573 | Catheter Gauge 15 Fr | In distribution |
| IPN035970 | Catheter Gauge 15 Fr | In distribution |
| IPN033034 | Length 19 cm | In distribution |
| IPN035673 | Catheter Gauge 15 Fr | In distribution |
| IPN035969 | Catheter Gauge 15 Fr | In distribution |
| IPN920514 | In distribution | |
| IPN033079 | Catheter Gauge 15 Fr | In distribution |
| IPN033077 | Catheter Gauge 15 Fr | In distribution |
| IPN920493 | In distribution | |
| IPN033025 | Catheter Gauge 15 Fr | In distribution |
| IPN033113 | Length 31 cm | In distribution |
| IPN035651 | Catheter Gauge 15 Fr | In distribution |
| IPN035971 | Catheter Gauge 15 Fr | In distribution |
| IPN032551 | Length 19 cm | In distribution |
| IPN033112 | Length 27 cm | In distribution |
| IPN035695 | Length 42 cm | In distribution |
| IPN032550 | Length 19 cm | In distribution |
| IPN035659 | Length 23 cm | In distribution |
| IPN914734 | In distribution | |
| IPN039803 | In distribution | |
| IPN920749 | In distribution | |
| IPN055269 | In distribution | |
| IPN033240 | Length 55 cm | In distribution |
| IPN033045 | Length 23 cm | In distribution |
| IPN032578 | Length 31 cm | In distribution |
| IPN035664 | Catheter Gauge 15 Fr | In distribution |
| IPN001175 | In distribution | |
| IPN001371 | In distribution | |
| IPN039802 | Length 42 cm | In distribution |
| IPN920508 | In distribution | |
| IPN055270 | In distribution | |
| IPN033039 | Length 27 cm | In distribution |
| IPN033118 | Catheter Gauge 15 Fr | In distribution |
| IPN032563 | Catheter Gauge 15 Fr | In distribution |
| IPN001185 | In distribution | |
| IPN920133 | In distribution | |
| IPN033110 | Catheter Gauge 15 Fr | In distribution |
| IPN033032 | Length 19 cm | In distribution |
| CS-15272-VFM | In distribution | |
| IPN035688 | Length 27 cm | In distribution |
| IPN920512 | In distribution | |
| IPN033050 | Length 31 cm | In distribution |
| IPN032588 | Length 50 cm | In distribution |
| IPN033118 | Length 50 cm | In distribution |
| IPN032548 | Catheter Gauge 15 Fr | In distribution |
| IPN032565 | Catheter Gauge 15 Fr | In distribution |
| IPN001366 | In distribution | |
| IPN920486 | In distribution | |
| IPN035699 | Length 55 cm | In distribution |
| IPN914824 | In distribution | |
| IPN001392 | In distribution | |
| CS-15362-SPM | In distribution | |
| IPN033044 | Catheter Gauge 15 Fr | In distribution |
| IPN001178 | In distribution | |
| ACS-15272-VF | In distribution | |
| IPN055263 | Length 23 cm | In distribution |
| IPN033041 | Catheter Gauge 15 Fr | In distribution |
| IPN032561 | Length 23 cm | In distribution |
| IPN033054 | Length 27 cm | In distribution |
| IPN001304 | In distribution | |
| IPN035656 | Catheter Gauge 15 Fr | In distribution |
| IPN033238 | Length 42 cm | In distribution |
| IPN033826 | Catheter Gauge 15 Fr | In distribution |
| IPN033024 | Length 19 cm | In distribution |
| IPN033106 | Length 23 cm | In distribution |
| IPN033055 | Length 27 cm | In distribution |
| IPN001300 | In distribution | |
| IPN001363 | In distribution | |
| IPN001401 | In distribution | |
| IPN033049 | Length 31 cm | In distribution |
| IPN033116 | Catheter Gauge 15 Fr | In distribution |
| CS-15272-SFX | In distribution | |
| IPN033822 | Length 23 cm | In distribution |
| CS-15272-X | Length 27.0 cm | In distribution |
| IPN032570 | Length 27 cm | In distribution |
| CS-15312-X | In distribution | |
| IPN033058 | Length 31 cm | In distribution |
| IPN033827 | Catheter Gauge 15 Fr | In distribution |
| IPN001182 | In distribution | |
| IPN035653 | Length 19 cm | In distribution |
| IPN032569 | Length 27 cm | In distribution |
| IPN033069 | Catheter Gauge 15 Fr | In distribution |
| IPN032547 | Length 19 cm | In distribution |
| CS-15192-VFIM | In distribution | |
| IPN001389 | In distribution | |
| IPN032575 | Catheter Gauge 15 Fr | In distribution |
| CS-15232-VFIM | In distribution | |
| IPN001395 | In distribution | |
| ACS-15272-VFI | In distribution | |
| IPN001308 | In distribution | |
| CS-15232-X | In distribution | |
| IPN033023 | Catheter Gauge 15 Fr | In distribution |
| IPN033120 | Catheter Gauge 15 Fr | In distribution |
| IPN033046 | Catheter Gauge 15 Fr | In distribution |
| IPN035654 | Length 19 cm | In distribution |
| IPN001356 | In distribution | |
| IPN033235 | Catheter Gauge 15 Fr | In distribution |
| IPN055271 | Length 27 cm | In distribution |
| IPN001378 | In distribution | |
| IPN001176 | In distribution | |
| IPN920784 | In distribution | |
| CS-15272-XM | In distribution | |
| IPN033108 | Length 23 cm | In distribution |
| IPN035685 | Catheter Gauge 15 Fr | In distribution |
| CS-15552-VF | In distribution | |
| IPN914828 | In distribution | |
| IPN033239 | Catheter Gauge 15 Fr | In distribution |
| IPN001377 | In distribution | |
| IPN001373 | In distribution | |
| CS-15192-VFI | In distribution | |
| IPN001303 | In distribution | |
| IPN033057 | Length 31 cm | In distribution |
| IPN032582 | Length 42 cm | In distribution |
| IPN920516 | In distribution | |
| IPN001309 | In distribution | |
| CS-15272-VFIM | In distribution | |
| IPN035660 | Catheter Gauge 15 Fr | In distribution |
| IPN920483 | In distribution | |
| IPN920138 | In distribution | |
| IPN032562 | Catheter Gauge 15 Fr | In distribution |
| IPN055260 | Length 23 cm | In distribution |
| IPN033080 | Length 50 cm | In distribution |
| CS-15232-SFX | In distribution | |
| IPN032567 | Length 27 cm | In distribution |
| IPN032564 | Catheter Gauge 15 Fr | In distribution |
| IPN001368 | In distribution | |
| IPN001365 | In distribution | |
| IPN035682 | Catheter Gauge 15 Fr | In distribution |
| IPN001177 | In distribution | |
| IPN033106 | Length 23 cm | In distribution |
| IPN033066 | Catheter Gauge 15 Fr | In distribution |
| IPN033081 | Length 55 cm | In distribution |
| IPN001397 | In distribution | |
| IPN001386 | In distribution | |
| IPN914825 | In distribution | |
| IPN033112 | Length 27 cm | In distribution |
| IPN033048 | Length 31 cm | In distribution |
| IPN035700 | Catheter Gauge 15 Fr | In distribution |
| IPN920755 | In distribution | |
| IPN033821 | Length 19 cm | In distribution |
| IPN001357 | In distribution | |
| IPN001181 | In distribution | |
| IPN001349 | In distribution | |
| CS-15322-SPM | In distribution | |
| IPN032568 | Length 27 cm | In distribution |
| IPN033028 | Length 23 cm | In distribution |
| IPN032558 | Catheter Gauge 15 Fr | In distribution |
| IPN001394 | In distribution | |
| IPN920509 | In distribution | |
| CS-15282-VSP | In distribution | |
| IPN001362 | In distribution | |
| IPN035671 | Catheter Gauge 15 Fr | In distribution |
| IPN920476 | In distribution | |
| IPN055265 | In distribution | |
| IPN919718 | In distribution | |
| IPN033078 | Catheter Gauge 15 Fr | In distribution |
| IPN033110 | Catheter Gauge 15 Fr | In distribution |
| IPN055266 | Length 19 cm | In distribution |
| IPN001352 | In distribution | |
| IPN035674 | Length 27 cm | In distribution |
| IPN033051 | Catheter Gauge 15 Fr | In distribution |
| IPN919717 | In distribution | |
| IPN032583 | Catheter Gauge 15 Fr | In distribution |
| IPN920479 | In distribution | |
| IPN033229 | Length 19 cm | In distribution |
| IPN032579 | Catheter Gauge 15 Fr | In distribution |
| IPN920745 | In distribution | |
| IPN033116 | Length 31 cm | In distribution |
| IPN001359 | In distribution | |
| IPN001400 | In distribution | |
| IPN055262 | In distribution | |
| IPN032552 | Catheter Gauge 15 Fr | In distribution |
| IPN033240 | Length 55 cm | In distribution |
| CS-15272-VFI | In distribution | |
| IPN033824 | Catheter Gauge 15 Fr | In distribution |
| CS-15552-VFI | In distribution | |
| IPN033035 | Length 19 cm | In distribution |
| IPN033820 | Length 19 cm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Split Cath® III | Medical Components Inc | 277 |
| Palindrome | Mozarc Medical US LLC | 139 |
| Titan HD | Medical Components Inc | 75 |
| ProGuide™ | Merit Medical Systems, Inc. | 72 |
| Hemo-Flow® | Medical Components Inc | 65 |
| DuraMax® | Merit Medical Systems, Inc. | 55 |
| CentrosFLO® | Merit Medical Systems, Inc. | 51 |
| BioFlo DuraMax® | Merit Medical Systems, Inc. | 51 |
| BioFlo | Navilyst Medical, Inc. | 45 |
| DuraFlow | AngioDynamics, Inc. | 37 |
| Mahurkar | Mozarc Medical US LLC | 37 |
| HemoSplit Long-Term Hemodialysis Catheter | Bard Access Systems, Inc. | 35 |
Showing 12 of 123. All products under Catheter, Hemodialysis, Implanted
Recalls Naming This Product
5 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 | 2026-04-10 | Class I | Nonconforming Material/Component | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure tim | 285 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-10 | Class I | Nonconforming Material/Component | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure tim | 92,827 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-10 | Class I | Nonconforming Material/Component | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure tim | 34,568 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2026-04-10 | Class I | Nonconforming Material/Component | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure tim | 19,687 | |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2013-02-04 | Class II | Component design/selection | The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit. | 2,480 | 2016-10-14 |
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.