Catheter, Peritoneal, Long-Term Indwelling
FDA product code FJS · Class II (moderate risk) · 21 CFR 876.5630 · Gastroenterology, Urology
48510(k) clearances
0PMA approvals
8recalls
Implantimplanted device
Manufacturers
- Quinton, Inc. 8
- Accurate Surgical Instruments Co. 7
- Medigroup 5
- Janin Group, Inc. 4
- Sil-Med Corp. 3
- Covidien LLC 2
- Dravon Medical, Inc. 2
- Medionics International , Ltd. 2
- Tabex Industries, Inc. 2
- Medical Components, Inc. 2
- Vas-Cath of Canada , Ltd. 1
- Pfm Medical, Inc. 1
- Med-Conduit, Inc. 1
- Lifemed of California 1
- Akcess Medical Products, Inc. 1
- Hdc Corp. 1
- Thermedics, Inc. 1
- Thermadics, Inc. 1
- W. L. Gore & Associates, Inc. 1
- American Medical Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional | Covidien, LLC | 01/14/2022SE |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional | Covidien, LLC | 07/27/2018SESK |
| K130441 | Faller StyletFJS · Traditional | Medionics International, Inc. | 04/19/2013SE |
| K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)FJS · Traditional | Medical Components, Inc. | 09/05/2012SESK |
| K120130 | Faller TrocarFJS · Traditional | Medigroup, Inc. | 05/21/2012SE |
| K113354 | Veta Peritoneal Dialysis CatheterFJS · Traditional | Pfm Medical, Inc. | 03/13/2012SESK |
| K071167 | Flex-Neck Exxtended Peritoneal Dialysis Catheter and Accessories, Model CF-5560FJS · Traditional | Medigroup, Inc. | 08/31/2007SESK |
| K070730 | Flex-Neck Arc CatheterFJS · Traditional | Medigroup, Inc. | 07/03/2007SESK |
| K060897 | Embedding Tool, Model TE-1000FJS · Traditional | Medigroup, Inc. | 07/18/2006SE |
| K053123 | PD CathFJS · Traditional | Med-Conduit, Inc. | 03/29/2006SE |
| K031351 | Flex-Neck PD Catheter, InfantFJS · Traditional | Medigroup, Inc. | 09/17/2003SE |
| K012502 | Medigroup Catheter Extender/Repair KitFJS · Traditional | Janin Group, Inc. | 02/04/2002SE |
| K013017 | Medigroup Key TubeFJS · Traditional | Janin Group, Inc. | 12/06/2001SE |
| K993149 | Peritoneal Dialysis Catheters and AdaptersFJS · Traditional | Medionics International, Inc. | 04/28/2000SE |
| K991042 | Ash Advantage Peritoneal CatheterFJS · Traditional | Janin Group, Inc. | 06/25/1999SE |
| K970159 | Flex-Neck PD CatheterFJS · Traditional | Janin Group, Inc. | 09/05/1997SE |
| K961392 | Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IIFJS · Traditional | Sil-Med Corp. | 07/18/1997SE |
| K950042 | Swan Neck Presternal Peritoneal Dialysis CatheterFJS · Traditional | Accurate Surgical Instruments Co. | 12/15/1995SE |
| K934610 | Cath Dome Pd- Water Resistant Cover for Indwelling Peritoneal Dialysis Catheters and…FJS · Traditional | Tabex Industries, Inc. | 09/23/1994SE |
| K930175 | Cath Belt PD Catheter and Transfer Set HolderFJS · Traditional | Tabex Industries, Inc. | 06/23/1994SE |
| K915490 | Medcomp Peritoneal Dialysis CathetersFJS · Traditional | Medical Components, Inc. | 02/02/1994SESK |
| K920515 | InsertionFJS · Traditional | Accurate Surgical Instruments Co. | 05/04/1992SE |
| K910786 | Trocar (Faller Stylet)FJS · Traditional | Accurate Surgical Instruments Co. | 09/19/1991SE |
| K910785 | Titanium Catheter ExtenderFJS · Traditional | Accurate Surgical Instruments Co. | 08/22/1991SE |
| K903502 | Lifecoil CatheterFJS · Traditional | Lifemed of California | 10/22/1990SE |
| K902101 | Peritoneal CathetersFJS · Traditional | Akcess Medical Products, Inc. | 07/27/1990SE |
| K890288 | Peritoneal Catheters with an Added FunctionFJS · Traditional | Quinton, Inc. | 03/27/1989SE |
| K885167 | Trudell Bent CatheterFJS · Traditional | Sil-Med Corp. | 01/31/1989SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | Vas-Cath of Canada , Ltd. | 07/16/1987SE |
| K863819 | Chemo-Cath Intraperitoneal CatheterFJS · Traditional | Hdc Corp. | 02/04/1987SE |
| K863128 | Peritoneal Dialysis CathetersFJS · Traditional | Thermedics, Inc. | 09/09/1986SE |
| K862046 | Swan-Neck Peritoneal Dialysis CathetersFJS · Traditional | Accurate Surgical Instruments Co. | 06/19/1986SE |
| K854614 | Long Term Peritoneal CatheterFJS · Traditional | Thermadics, Inc. | 12/19/1985SE |
| K850214 | Sterile Catheters-Catheter Peritoneal Long-Term inFJS · Traditional | Accurate Surgical Instruments Co. | 07/26/1985SE |
| K820909 | Gore-Tex Peritoneal CatheterrFJS · Traditional | W. L. Gore & Associates, Inc. | 05/21/1982SE |
| K813488 | Catheter RegularFJS · Traditional | Accurate Surgical Instruments Co. | 12/31/1981SE |
| K812718 | Cuff Material on Pediatric Size Cath.FJS · Traditional | Quinton, Inc. | 10/19/1981SE |
| K812607 | Tenckhoff Peritoneal CathetersFJS · Traditional | Quinton, Inc. | 10/02/1981SE |
| K810236 | Miromed Peritoneal Dialysis CatheterFJS · Traditional | American Medical Products, Inc. | 03/13/1981SE |
| K801818 | Tenckhoff CatheterFJS · Traditional | Sil-Med Corp. | 10/23/1980SE |
| K801679 | Beta-Cap IIFJS · Traditional | Quinton, Inc. | 10/03/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | Dravon Medical, Inc. | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | Dravon Medical, Inc. | 02/27/1979SE |
| K780449 | Beta Cap SystemFJS · Traditional | Quinton, Inc. | 05/16/1978SE |
| K780643 | Shadow-CathsFJS · Traditional | Quinton, Inc. | 04/27/1978SE |
| K771555 | Peritoneal Dialysis CatheterFJS · Traditional | Fluoro-Mold Co. | 11/28/1977SE |
| K771483 | Catheter Finger GripFJS · Traditional | Quinton, Inc. | 11/28/1977SE |
| K771420 | Beta-CapFJS · Traditional | Quinton, Inc. | 11/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1352-2023 Class II | Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/AProduct that was built for design verification testing was inadvertently distributed to customers. | Merit Medical Systems, Inc. | 02/15/2023Open, Classified |
| Z-2823-2018 Class II | Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient…Mix-up between adult and pediatrics PD catheter. | Merit Medical Systems, Inc. | 12/20/2017Terminated |
| Z-1143-2018 Class II | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. | Merit Medical Systems, Inc. | 09/20/2017Terminated |
| Z-0568-2015 Class II | ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to…PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for… | Pfm Medical Inc | 10/20/2014Terminated |
| Z-2962-2011 | Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal…Labeling for drainage kit contained incomplete information. | Bard Access Systems | 05/21/2011Terminated |
| Z-2961-2011 | Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | Bard Access Systems | 05/21/2011Terminated |
| Z-2960-2011 | Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | Bard Access Systems | 05/21/2011Terminated |
| Z-2959-2011 | Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is…Labeling for drainage kit contained incomplete information. | Bard Access Systems | 05/21/2011Terminated |