Product code LFK
- Device name
- Catheter, Femoral
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971897 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) | Medron, Inc. | 1997-10-21 |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Akcess Medical Products, Inc. | 1992-04-23 |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Akcess Medical Products, Inc. | 1992-03-27 |
| K891763 | FC-100 FEMORAL CATHETER | Akcess Medical Products, Inc. | 1989-04-07 |
| K891764 | FC-101 FEMORAL CATHETER GUIDE WIRE | Akcess Medical Products, Inc. | 1989-04-07 |
| K890717 | MODIFICATION HEMOFILTRATION CATHETER HF-100 | Vas-Cath, Inc. | 1989-04-05 |
| K880775 | CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY | Medsurg Industries, Inc. | 1988-07-25 |
| K882466 | VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER | Vas-Cath, Inc. | 1988-07-13 |
| K865096 | NEW SECOND FRENCH SIZE MAHURKAR CATHETER | Quinton, Inc. | 1987-02-18 |
| K863218 | CYTOSTATIC FILTRATION SET | Meadox Surgimed, Inc. | 1987-02-12 |
| K862771 | MEDCOMP C.A.V.H. CATHETER | Medical Components, Inc. | 1986-08-06 |
| K860810 | MEDCOMP'S FEMORAL VEIN CATHETERS | Medical Components, Inc. | 1986-04-08 |
| K854612 | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 | Med-West, Inc. | 1986-01-03 |
| K831828 | TEFLON FEMORAL CATHETER MWI 100,10 & | Med-West, Inc. | 1983-07-07 |
| K830674 | MAHURKAR FEMORAL CATHETER | Quinton, Inc. | 1983-05-18 |
| K820237 | COBE ACUFLEX FSN, #15-208 | Cobe Laboratories, Inc. | 1982-03-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50884908055899 | CAVH Catheter | Medical Components, Inc. | 2016-04-29 |
| 50884908029951 | CAVH Catheter | Medical Components, Inc. | 2016-04-29 |
| 00884908029956 | CAVH Catheter | Medical Components, Inc. | 2016-04-29 |
| 00884908055894 | CAVH Catheter | Medical Components, Inc. | 2016-04-29 |
| 50884908029937 | CAVH CATHETER | Medical Components, Inc. | 2016-02-27 |
| 00884908029932 | CAVH CATHETER | Medical Components, Inc. | 2016-02-27 |
| 00884908029970 | CAVH CATHETER | Medical Components, Inc. | 2016-02-27 |
| 00884908053968 | Femoral Catheter | Medical Components, Inc. | 2016-02-27 |
| 50884908029975 | CAVH CATHETER | Medical Components, Inc. | 2016-02-27 |
| 50884908053963 | Femoral Catheter | Medical Components, Inc. | 2016-02-27 |
| 00884908026757 | STRAIGHT FEMORAL | Medical Components, Inc. | 2015-11-17 |
| 50884908026752 | STRAIGHT FEMORAL | Medical Components, Inc. | 2015-11-17 |
| 00884908053999 | Femoral Catheter | Medical Components, Inc. | 2015-11-11 |
| 50884908053994 | Femoral Catheter | Medical Components, Inc. | 2015-11-11 |
| 00884908056181 | CAVH Catheter | Medical Components, Inc. | 2015-10-24 |
| 00884908054361 | Femoral Catheter | Medical Components, Inc. | 2015-10-24 |
| 50884908054366 | Femoral Catheter | Medical Components, Inc. | 2015-10-24 |
| 50884908056186 | CAVH Catheter | Medical Components, Inc. | 2015-10-24 |
| 00884908026665 | Femoral Catheter | Medical Components, Inc. | 2015-10-23 |
| 50884908029715 | CAVH Catheter | Medical Components, Inc. | 2015-10-23 |
| 50884908029395 | CAVH Catheter | Medical Components, Inc. | 2015-10-23 |
| 50884908026660 | Femoral Catheter | Medical Components, Inc. | 2015-10-23 |
| 00884908029710 | CAVH Catheter | Medical Components, Inc. | 2015-10-23 |
| 00884908029390 | CAVH Catheter | Medical Components, Inc. | 2015-10-23 |
| H787103003015 | DuraFlow | ANGIODYNAMICS, INC. | 2015-09-15 |
| H787103003010 | DuraFlow | ANGIODYNAMICS, INC. | 2015-09-15 |