FDA product code LFJ: Catheter, Subclavian
LFJ is the FDA product code for catheter, subclavian. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 65 510(k) submissions under LFJ, from 22 different applicants. The average 510(k) review took 144 days (median 78). FDA has posted 6 recalls for LFJ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Subclavian |
| 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 |
Compare with all 510(k) review times · Search every LFJ clearance
Top LFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akcess Medical Products, Inc. | 12 | 1994-08-02 |
| Quinton, Inc. | 8 | 1990-05-09 |
| Vas-Cath of Canada , Ltd. | 8 | 1988-03-02 |
| Shiley, Inc. | 7 | 1988-04-27 |
| Vas-Cath, Inc. | 5 | 1993-07-01 |
17 more applicants have LFJ clearances. See the full list in Caduvo.
Most recent LFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920780 | Medsurg Industries, Inc. | MEDSURG INSERTION TRAY | 1994-08-19 | 911 |
| K925819 | Akcess Medical Products, Inc. | AKCESS0CATH KIT | 1994-08-02 | 623 |
| K925818 | Akcess Medical Products, Inc. | AKCESS-CATH | 1994-04-05 | 504 |
| K913468 | Cook, Inc. | ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY | 1994-03-24 | 962 |
| K931120 | Akcess Medical Products, Inc. | COAXIAL ACUTE CATHETER | 1994-01-14 | 316 |
Recalls for LFJ devices
6 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LFJ?
LFJ is the FDA product code for catheter, subclavian. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is LFJ?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFJ?
Across 65 cleared submissions the average was 144 days from receipt to decision (median 78).
Which companies have the most LFJ clearances?
Akcess Medical Products, Inc. (12); Quinton, Inc. (8); Vas-Cath of Canada , Ltd. (8); Shiley, Inc. (7); Vas-Cath, Inc. (5).
Have LFJ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LFJ
- Run a recall and safety report across every LFJ manufacturer
- Watch product code LFJ 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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