K895548 is an FDA 510(k) clearance for the CONVEEN INTERMITTENT CATHETERS. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on February 9, 1990, 149 days after receiving the submission on September 13, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K895548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1989 |
| Decision Date | February 09, 1990 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |