K926374 is an FDA 510(k) clearance for the SILICONE CATHETER REPAIR KITS. This device is classified as a Accessories, Blood Circuit, Hemodialysis (Class II — Special Controls, product code KOC).
Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on October 7, 1994, 654 days after receiving the submission on December 22, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K926374 FDA.gov |
| FDA Decision | Cleared SESK |
| Date Received | December 22, 1992 |
| Decision Date | October 07, 1994 |
| Days to Decision | 654 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOC — Accessories, Blood Circuit, Hemodialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5820 |