Catheter, Femoral
FDA product code LFK · Class II (moderate risk) · 21 CFR 876.5540 · Gastroenterology, Urology
16510(k) clearances
0PMA approvals
7recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971897 | Continuous Arteriovenous Hemofiltration Catheter 10 FR (Cavh)LFK · Traditional | Medron, Inc. | 10/21/1997SE |
| K914936 | Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional | Akcess Medical Products, Inc. | 04/23/1992SESK |
| K915215 | Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional | Akcess Medical Products, Inc. | 03/27/1992SESK |
| K891764 | FC-101 Femoral Catheter Guide WireLFK · Traditional | Akcess Medical Products, Inc. | 04/07/1989SE |
| K891763 | FC-100 Femoral CatheterLFK · Traditional | Akcess Medical Products, Inc. | 04/07/1989SE |
| K890717 | Modification Hemofiltration Catheter HF-100LFK · Traditional | Vas-Cath, Inc. | 04/05/1989SE |
| K880775 | Continuous Arterial/Venous Hemofiltration TrayLFK · Traditional | Medsurg Industries, Inc. | 07/25/1988SESD |
| K882466 | Vas-Cath Pediatric Hemofiltration CatheterLFK · Traditional | Vas-Cath, Inc. | 07/13/1988SE |
| K865096 | New Second French Size Mahurkar CatheterLFK · Traditional | Quinton, Inc. | 02/18/1987SESD |
| K863218 | Cytostatic Filtration SetLFK · Traditional | Meadox Surgimed, Inc. | 02/12/1987SE |
| K862771 | Medcomp C.A.V.H. CatheterLFK · Traditional | Medical Components, Inc. | 08/06/1986SE |
| K860810 | Medcomp's Femoral Vein CathetersLFK · Traditional | Medical Components, Inc. | 04/08/1986SE |
| K854612 | Acute Hemodialysis Tray, CAT.#09-9540-7LFK · Traditional | Med-West, Inc. | 01/03/1986SESD |
| K831828 | Teflon Femoral Catheter Mwi 100,10 &LFK · Traditional | Med-West, Inc. | 07/07/1983SE |
| K830674 | Mahurkar Femoral CatheterLFK · Traditional | Quinton, Inc. | 05/18/1983SE |
| K820237 | Cobe Acuflex FSN, #15-208LFK · Traditional | Cobe Laboratories, Inc. | 03/10/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2615-2016 Class II | FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used…Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.… | Cook Inc. | 04/15/2016Terminated |
| Z-0180-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |
| Z-0179-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |
| Z-0178-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |
| Z-0177-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |
| Z-0176-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |
| Z-0175-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator…The firm received several complaints sighting detachment of the balloon at the distal end of the shaft. It… | ConMed Corporation | 09/08/2008Terminated |