K821745 is an FDA 510(k) clearance for the BARDEX ALL SILICONE PEDIATRIC CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on June 24, 1982, 10 days after receiving the submission on June 14, 1982.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K821745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1982 |
| Decision Date | June 24, 1982 |
| Days to Decision | 10 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 |