Panels › Gastroenterology, Urology › Product code FKA · Class 2
Dilator, Vessel
Regulation 876.5540
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FKA
| Company | 510(k)s | Recalls |
|---|---|---|
| Akcess Medical Products, Inc. | 1 | 0 |
| Spire Biomedical, Inc. | 1 | 0 |
| Vas-Cath, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 11, 2002 | K022620 | SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT Spire Biomedical, Inc. | FKA |
| Jul 1, 1993 | K914210 | VAS-CATH DUALATOR(TM) VESSEL DILATOR Vas-Cath, Inc., CA | FKA |
| Apr 29, 1991 | K910502 | VESSEL DILATORS Akcess Medical Products, Inc. | FKA |
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