K911329 is an FDA 510(k) clearance for the BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE. This device is classified as a Bag, Urine Collection, Newborn (Class II - Special Controls, product code FOC).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on May 28, 1991, 63 days after receiving the submission on March 26, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K911329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1991 |
| Decision Date | May 28, 1991 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FOC — Bag, Urine Collection, Newborn |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |