K040658 is an FDA 510(k) clearance for the BARDEX I.C. LATEX FOLEY CATHETER. This device is classified as a Catheter, Urological (antimicrobial) And Accessories (Class II - Special Controls, product code MJC).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on September 29, 2004, 201 days after receiving the submission on March 12, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K040658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2004 |
| Decision Date | September 29, 2004 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MJC — Catheter, Urological (antimicrobial) And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |