K891763 is an FDA 510(k) clearance for the FC-100 FEMORAL CATHETER. This device is classified as a Catheter, Femoral (Class II - Special Controls, product code LFK).
Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on April 7, 1989, 14 days after receiving the submission on March 24, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K891763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1989 |
| Decision Date | April 07, 1989 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LFK — Catheter, Femoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |