Catheter, Femoral
A femoral catheter is a vascular access device inserted via the femoral vein or artery and used for hemodialysis, hemodynamic monitoring, or the administration of fluids and medications in critically ill or renally impaired patients. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LFK and is regulated under 21 CFR 876.5540 within the Gastroenterology and Urology specialty. This device is flagged as both an implant and a life-sustaining or life-supporting device, reflecting its critical role in patient care.
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Basic Information
- Product Code
- LFK
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K971897 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) | Oct 21, 1997 | Substantially Equivalent | Medron, Inc. |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Apr 23, 1992 | Unknown | Akcess Medical Products, Inc. |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Mar 27, 1992 | Unknown | Akcess Medical Products, Inc. |
| K891764 | FC-101 FEMORAL CATHETER GUIDE WIRE | Apr 07, 1989 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K891763 | FC-100 FEMORAL CATHETER | Apr 07, 1989 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K890717 | MODIFICATION HEMOFILTRATION CATHETER HF-100 | Apr 05, 1989 | Substantially Equivalent | Vas-Cath, Inc. |
| K880775 | CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY | Jul 25, 1988 | Unknown | Medsurg Industries, Inc. |
| K882466 | VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER | Jul 13, 1988 | Substantially Equivalent | Vas-Cath, Inc. |
| K865096 | NEW SECOND FRENCH SIZE MAHURKAR CATHETER | Feb 18, 1987 | Unknown | Quinton, Inc. |
| K863218 | CYTOSTATIC FILTRATION SET | Feb 12, 1987 | Substantially Equivalent | Meadox Surgimed, Inc. |
| K862771 | MEDCOMP C.A.V.H. CATHETER | Aug 06, 1986 | Substantially Equivalent | Medical Components, Inc. |
| K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS | Apr 08, 1986 | Substantially Equivalent | Medical Components, Inc. |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Jan 03, 1986 | Unknown | Med-West, Inc. |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Jul 07, 1983 | Substantially Equivalent | Med-West, Inc. |
| K830674 | MAHURKAR FEMORAL CATHETER | May 18, 1983 | Substantially Equivalent | Quinton, Inc. |
| K820237 | COBE ACUFLEX FSN, #15-208 | Mar 10, 1982 | Substantially Equivalent | Cobe Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.