K922431 is an FDA 510(k) clearance for the BARD LATEX URINARY CATHETERS. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 25, 1993, 307 days after receiving the submission on May 22, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K922431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 22, 1992 |
| Decision Date | March 25, 1993 |
| Days to Decision | 307 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |