K910195 is an FDA 510(k) clearance for the BARD HYDROGEL-COATED FOLEY CATHETERS. This device is classified as a Catheter, Coude (Class II - Special Controls, product code EZC).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 9, 1991, 205 days after receiving the submission on January 16, 1991.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K910195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1991 |
| Decision Date | August 09, 1991 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EZC — Catheter, Coude |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |