Catheter, Hemodialysis, Non-Implanted
FDA product code MPB · Class II (moderate risk) · 21 CFR 876.5540 · Gastroenterology, Urology
38510(k) clearances
0PMA approvals
21recalls
Manufacturers
- Medical Components, Inc. 6
- Quinton, Inc. 5
- C.R. Bard, Inc. 5
- Arrow Intl., Inc. 3
- Gambro Renal Products 2
- Cook, Inc. 2
- Covidien LLC 2
- Keystone Medical 1
- Deltec, Inc. 1
- Kendall 1
- Vas-Cath, Inc. 1
- Jms North America Corp. 1
- Novosci Corp. 1
- Nipro Medical Corporation 1
- Foshan Nanhai Bai HE Medical Technology Co., Ltd. 1
- Ameco Medical Industries 1
- Kendall Healthcare Products Co. Div.Of Tyco Health 1
- B. Braun Medical, Inc. 1
- Medical Components, Inc dba MedComp 1
- Health Line International Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. | 08/12/2025SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | Health Line International Corporation | 12/24/2020SESK |
| K192807 | Duo-Flow Side x Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. (dba MedComp) | 04/23/2020SE |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…MPB · Traditional | Covidien, LLC | 01/17/2020SEKD |
| K163458 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 04/04/2017SEKD |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayMPB · Special | Cook Incorporated | 01/06/2017SEKD |
| K153190 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 01/05/2016SE |
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…MPB · Traditional | Cook, Inc. | 07/29/2013SESK |
| K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterMPB · Special | Covidien | 04/04/2012SESK |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
| K102833 | Disposable Hemodialysis Access Catheter SetsMPB · Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 11/18/2011SE |
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…MPB · Traditional | Gambro Renal Products, Inc. | 12/21/2010SE |
| K090102 | Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersMPB · Special | C.R. Bard, Inc. | 02/12/2009SEKD |
| K071145 | Nipro Safetouch Tulip Safety Fistula NeedleMPB · Abbreviated | Nipro Medical Corporation | 09/07/2007SE |
| K063355 | D-Line Catheter ST, Double Lumen ST; Extra FlowMPB · Traditional | Novosci Corp. | 07/27/2007SESK |
| K070234 | JMS Sysloc Mini Avf and Apheresis Needle SetsMPB · Special | Jms North America Corp. | 05/22/2007SE |
| K040301 | Gamcath High Flow Catheter, Ref: GDHK 13XX aMPB · Traditional | Gambro Renal Products | 11/01/2004SESK |
| K030268 | Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen CathetersMPB · Abbreviated | C.R. Bard, Inc. | 07/30/2003SE |
| K030209 | Mahurkar Oplus Catheter, Model 13.5 FRMPB · Traditional | The Kendall Company | 05/13/2003SE |
| K022221 | Truflow Long-Term and Short-Term Dual-Lumen Dialysis CathetersMPB · Traditional | Deltec, Inc. | 01/30/2003SESK |
| K010778 | Niagara Slim-CathMPB · Special | C.R. Bard, Inc. | 04/13/2001SE |
| K001958 | Keystone Medical Schon XL Soft-Line Double Lument Catheter. Keystone Medical 12 F…MPB · Traditional | Keystone Medical | 09/25/2000SE |
| K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…MPB · Traditional | Arrow Intl., Inc. | 09/14/2000SE |
| K991320 | Medcomp Duo-Flow II Catheter with Lubricious HeparinMPB · Traditional | Medical Components, Inc. | 11/10/1999SE |
| K980438 | 11.5F X 6 (15CM) Duo-Split Catheter MCDS116MT, 11.5F X 8 (20CM) Duo-Split Catheter…MPB · Traditional | Medical Components, Inc. | 06/10/1999SE |
| K983511 | Soft-Line Ij Double Lumen Catheter 11.5FR X 12CM, Soft-Line Ij Double Lumen Catheter…MPB · Traditional | Medical Components, Inc. | 06/08/1999SE |
| K991431 | 14 Fr. Hemodialysis Two-Lumen Catheterization KitMPB · Special | Arrow Intl., Inc. | 05/26/1999SE |
| K984022 | Pediatric Two-Lumen Hemodialysis Catherization KitMPB · Traditional | Arrow Intl., Inc. | 05/18/1999SE |
| K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon XL…MPB · Traditional | Medical Components, Inc. | 04/15/1999SE |
| K965178 | Niagara Dual Lumen CatheterMPB · Traditional | Vas-Cath, Inc. | 08/19/1997SE |
| K963446 | Kendall Dual Lumen CatheterMPB · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 03/18/1997SE |
| K952660 | Braun Hemodialysis CatheterMPB · Traditional | B.Braun Medical, Inc. | 09/17/1996SE |
| K955002 | Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional | Quinton, Inc. | 09/13/1996SE |
| K923691 | Twin Silicone CatheterMPB · Traditional | Medical Components, Inc. | 09/25/1995SESK |
| K896252 | Modified Quinton Single Lumen CatheterMPB · Traditional | Quinton, Inc. | 01/29/1990SE |
| K893188 | Quinton Single Lumen CatheterMPB · Traditional | Quinton, Inc. | 06/08/1989SE |
| K880583 | Modified Formed-Extension Mahurkar Dual Lumen CathMPB · Traditional | Quinton, Inc. | 02/22/1988SE |
| K871360 | 10F & 11.5F Mahurkar Dual Lumen Catheters, UseableMPB · Traditional | Quinton, Inc. | 04/29/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2985-2026 | DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term…this is a downstream recall of class I recall RES 98777 | Bard Access Systems, Inc. | 08/10/2026Open, Classified |
| Z-2984-2026 | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis…this is a downstream recall of class I recall RES 98777 | Bard Access Systems, Inc. | 08/10/2026Open, Classified |
| Z-2319-2026 Class II | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual…The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite… | Mozarc Medical US LLC | 04/29/2026Open, Classified |
| Z-2373-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2942-2018 Class II | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2941-2018 Class II | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2940-2018 Class II | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98MThe suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2939-2018 Class II | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2938-2018 Class II | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2937-2018 Class II | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2936-2018 Class II | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2935-2018 Class II | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJThe suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2934-2018 Class II | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2933-2018 Class II | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-2932-2018 Class II | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107…The suture wings have the potential to crack or break. Potential patient injury includes catheter… | Medical Components, Inc dba MedComp | 07/12/2018Terminated |
| Z-1336-2018 Class II | ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1)…Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot… | Arrow International Inc | 12/22/2017Terminated |
| Z-0658-2018 Class II | ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions…These finished good kits may contain the incorrect Springwire Guide (SWG). | Arrow International Inc | 10/17/2017Terminated |
| Z-1007-2018 Class II | MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions…Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis… | Medtronic Minimally Invasive Therapies Group | 10/14/2017Terminated |
| Z-2334-2017 Class II | 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume…Arrow International is recalling the affected product because the packaging may not be completely sealed… | Arrow International Inc | 05/09/2017Terminated |
| Z-2405-2015 Class II | RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18…Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis… | Cordis Corporation | 04/15/2014Terminated |
| Z-1229-2007 | Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems…Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential… | C.R. Bard Access Systems, Inc | 08/10/2007Terminated |