FDA product code LFK: Catheter, Femoral
LFK is the FDA product code for catheter, femoral. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 16 510(k) submissions under LFK, from 9 different applicants. The average 510(k) review took 74 days (median 48). FDA has posted 7 recalls for LFK devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Femoral |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every LFK clearance
Top LFK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akcess Medical Products, Inc. | 4 | 1992-04-23 |
| Vas-Cath, Inc. | 2 | 1989-04-05 |
| Quinton, Inc. | 2 | 1987-02-18 |
| Medical Components, Inc. | 2 | 1986-08-06 |
| Med-West, Inc. | 2 | 1986-01-03 |
4 more applicants have LFK clearances. See the full list in Caduvo.
Most recent LFK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971897 | Medron, Inc. | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH) | 1997-10-21 | 152 |
| K914936 | Akcess Medical Products, Inc. | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | 1992-04-23 | 171 |
| K915215 | Akcess Medical Products, Inc. | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | 1992-03-27 | 130 |
| K891763 | Akcess Medical Products, Inc. | FC-100 FEMORAL CATHETER | 1989-04-07 | 14 |
| K891764 | Akcess Medical Products, Inc. | FC-101 FEMORAL CATHETER GUIDE WIRE | 1989-04-07 | 14 |
Recalls for LFK devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-15.
Frequently asked questions
What is FDA product code LFK?
LFK is the FDA product code for catheter, femoral. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is LFK?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFK?
Across 16 cleared submissions the average was 74 days from receipt to decision (median 48).
Which companies have the most LFK clearances?
Akcess Medical Products, Inc. (4); Vas-Cath, Inc. (2); Quinton, Inc. (2); Medical Components, Inc. (2); Med-West, Inc. (2).
Have LFK devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2016-04-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LFK
- Run a recall and safety report across every LFK manufacturer
- Watch product code LFK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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