K905016 is an FDA 510(k) clearance for the PEDIATRIC AND INFANT CATH KITS. This device is classified as a Collector, Urine, Pediatric, For Indwelling Catheter (Class II - Special Controls, product code FFH).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on December 20, 1990, 43 days after receiving the submission on November 7, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K905016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | November 07, 1990 |
| Decision Date | December 20, 1990 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFH — Collector, Urine, Pediatric, For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |