Catheter, Subclavian
FDA product code LFJ · Class II (moderate risk) · 21 CFR 876.5540 · Gastroenterology, Urology
65510(k) clearances
0PMA approvals
6recalls
Implantimplanted device
Manufacturers
- Akcess Medical Products, Inc. 12
- Vas-Cath of Canada , Ltd. 8
- Quinton, Inc. 8
- Shiley, Inc. 7
- Medical Components, Inc. 5
- Vas-Cath, Inc. 5
- Medcomp 3
- Impra, Inc. 2
- Medsurg Industries, Inc. 2
- Cook, Inc. 1
- Vygon Corp. 1
- Arrow Intl., Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Deseret Medical, Inc. 1
- Gish Biomedical, Inc. 1
- Med-West, Inc. 1
- Abbott Laboratories 1
- Renal Systems, Inc. 1
- Holter-Hausner Intl. 1
- Cobe Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | Medsurg Industries, Inc. | 08/19/1994SEKD |
| K925819 | AKCESS0CATH KitLFJ · Traditional | Akcess Medical Products, Inc. | 08/02/1994SE |
| K925818 | Akcess-CathLFJ · Traditional | Akcess Medical Products, Inc. | 04/05/1994SE |
| K913468 | Uldall Double Lumen Hemodialysis Catheter Set/TrayLFJ · Traditional | Cook, Inc. | 03/24/1994SE |
| K931120 | Coaxial Acute CatheterLFJ · Traditional | Akcess Medical Products, Inc. | 01/14/1994SE |
| K920634 | Splittable Sheath Introducer SetLFJ · Traditional | Akcess Medical Products, Inc. | 01/14/1994SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | Vas-Cath, Inc. | 07/01/1993SE |
| K915423 | Hemo-Cath Silicone Access CatheterLFJ · Traditional | Medical Components, Inc. | 02/02/1993SESK |
| K914826 | Akcess-Cath KitLFJ · Traditional | Akcess Medical Products, Inc. | 04/10/1992SESK |
| K910501 | Permanent Silicone CathetersLFJ · Traditional | Akcess Medical Products, Inc. | 04/29/1991SE |
| K905080 | Med-West Dual Lumen Internal Jugular CatheterLFJ · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 01/31/1991SE |
| K904139 | Single Lumen Catheter KitsLFJ · Traditional | Akcess Medical Products, Inc. | 12/04/1990SESK |
| K904140 | Single Lumen Catheters, ModificationLFJ · Traditional | Akcess Medical Products, Inc. | 11/27/1990SE |
| K901133 | DuracathLFJ · Traditional | Impra, Inc. | 06/08/1990SE |
| K901061 | Sub-Clavian Catheters SLSC 1300, 1500 and 2000LFJ · Traditional | Akcess Medical Products, Inc. | 05/22/1990SE |
| K900835 | Modified Perm-CathLFJ · Traditional | Quinton, Inc. | 05/09/1990SE |
| K896568 | Dualyse-Cath - Codes #1132.212, 1132.112LFJ · Traditional | Vygon Corp. | 05/09/1990SE |
| K900803 | Dual Lumen Sub-Clavian Catheters DLSC 600S & 800SLFJ · Traditional | Akcess Medical Products, Inc. | 04/25/1990SE |
| K895506 | Flexxicon Plus Dual Lumen Dialysis CatheterLFJ · Traditional | Vas-Cath, Inc. | 02/09/1990SE |
| K895417 | Arrow Large-Bore Dual Lumen Hemodialysis KitLFJ · Traditional | Arrow Intl., Inc. | 01/03/1990SE |
| K893439 | Hemo-Cath Silicone Double Lumen Cath SL28C & SL40CLFJ · Traditional | Medical Components, Inc. | 06/13/1989SE |
| K891755 | Dual Lumen Sub-Clavian Cath Kit, DLSC 600K & 800KLFJ · Traditional | Akcess Medical Products, Inc. | 06/08/1989SE |
| K891753 | Dual Lumen Sub-Clavian Catheter, DLSC 600 & 800LFJ · Traditional | Akcess Medical Products, Inc. | 06/08/1989SE |
| K884322 | Subclavian Hemodialysis CatheterLFJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/25/1989SE |
| K890029 | Hemo-Cath Silicone Double Lumen CatheterLFJ · Traditional | Medical Components, Inc. | 04/17/1989SE |
| K890099 | Modified Vas-Cath Catheter Repair KitLFJ · Traditional | Vas-Cath, Inc. | 04/11/1989SE |
| K883592 | Impra Dual Lumen Subclavian - Femoral CatheterLFJ · Traditional | Impra, Inc. | 12/08/1988SESD |
| K883768 | Vas-Cath Catheter Repair KitLFJ · Traditional | Vas-Cath, Inc. | 11/14/1988SE |
| K880778 | Medsurg Acute Dialysis TrayLFJ · Traditional | Medsurg Industries, Inc. | 07/15/1988SE |
| K881743 | Vas-Cath Flexxicon Dual Lumen Dialysis CatheterLFJ · Traditional | Vas-Cath, Inc. | 06/23/1988SE |
| K881695 | Deseret Subclavian Hemodialysis CatheterLFJ · Traditional | Deseret Medical, Inc. | 06/23/1988SE |
| K881290 | Modified Shiley Dual Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 04/27/1988SE |
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | Vas-Cath of Canada , Ltd. | 03/02/1988SE |
| K874633 | Permcath Insertion TrayLFJ · Traditional | Quinton, Inc. | 02/17/1988SESD |
| K871942 | Perm-Cath Catheter KitLFJ · Traditional | Quinton, Inc. | 06/17/1987SE |
| K871749 | Adult Perm-Cath 40CM.LFJ · Traditional | Quinton, Inc. | 06/17/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | Vas-Cath of Canada , Ltd. | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | Vas-Cath of Canada , Ltd. | 06/12/1987SE |
| K870328 | Single Lumen Acute CatheterLFJ · Traditional | Quinton, Inc. | 05/11/1987SE |
| K863697 | Modified Silicone Dual Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 10/02/1986SE |
| K861174 | Shiley Silicone Dual Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 04/23/1986SE |
| K860094 | Hurwitz Dialysis CatheterLFJ · Traditional | Gish Biomedical, Inc. | 04/07/1986SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | Vas-Cath of Canada , Ltd. | 08/22/1985SE |
| K852070 | Shiley Silicone Sual Lumen Subclavian CannualLFJ · Traditional | Shiley, Inc. | 06/13/1985SE |
| K852162 | Mni 400 Injection CapsLFJ · Traditional | Med-West, Inc. | 06/12/1985SE |
| K844434 | Vaccess 3000 Single Lumen Jugular Cannula-CathLFJ · Traditional | Vas-Cath of Canada , Ltd. | 03/13/1985SE |
| K844433 | Vaccess 2000 Single Lumen Subclavian CannulaLFJ · Traditional | Vas-Cath of Canada , Ltd. | 03/13/1985SE |
| K844336 | Vas-Cath Parallel Dual Luman Jugular Cannual CathLFJ · Traditional | Vas-Cath of Canada , Ltd. | 03/13/1985SE |
| K840197 | Single Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 04/25/1984SE |
| K833848 | Dual Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 12/08/1983SE |
| K830438 | Mcdlsck 126 Double Lumen Subclavian-FemLFJ · Traditional | Medcomp | 03/17/1983SE |
| K823135 | Double Lumen Subclavian CatheterLFJ · Traditional | Abbott Laboratories | 03/07/1983SE |
| K822964 | Right Atrial CatheterLFJ · Traditional | Quinton, Inc. | 11/30/1982SE |
| K822910 | Right Arterial CatheterLFJ · Traditional | Quinton, Inc. | 11/29/1982SE |
| K822134 | Shiely Duel Lumen Subclavian CannulaLFJ · Traditional | Shiley, Inc. | 08/03/1982SE |
| K821001 | Mcparland Scalp Vein CatheterLFJ · Traditional | Renal Systems, Inc. | 07/22/1982SE |
| K821955 | MCSCK638 Catheter in a Tray (Kit)LFJ · Traditional | Medcomp | 07/14/1982SE |
| K821954 | MCSCK838 Catheter in a Tray (Kit)LFJ · Traditional | Medcomp | 07/14/1982SE |
| K821684 | MCSCP8PS with 'Y' HubLFJ · Traditional | Medical Components, Inc. | 06/24/1982SE |
| K821400 | Mahurkar Subclavian CatheterLFJ · Traditional | Quinton, Inc. | 06/23/1982SE |
| K821012 | H-H Alimentation CathetersLFJ · Traditional | Holter-Hausner Intl. | 05/28/1982SE |
| K820238 | Cobe Acuflex SSN, #15-220LFJ · Traditional | Cobe Laboratories, Inc. | 03/10/1982SE |
| K812326 | Sorenson Subclavian Catheter SSC-8LFJ · Traditional | Sorensen Research | 09/25/1981SE |
| K810745 | Double Lumen Subclavin Catheter SC-400LFJ · Traditional | Vas-Cath of Canada , Ltd. | 03/31/1981SE |
| K801672 | Medcomp Subclavian CatheterLFJ · Traditional | Medical Components, Inc. | 12/18/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2381-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-FLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2217-2019 Class II | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.…Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | Medical Components, Inc dba MedComp | 03/13/2019Terminated |
| Z-2216-2019 Class II | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.…Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | Medical Components, Inc dba MedComp | 03/13/2019Terminated |
| Z-2215-2019 Class II | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.…Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | Medical Components, Inc dba MedComp | 03/13/2019Terminated |
| Z-1149-2019 Class II | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | Medical Components, Inc dba MedComp | 03/13/2019Terminated |
| Z-1083-2015 Class II | Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT…Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization… | Medical Components, Inc dba MedComp | 01/21/2015Terminated |