K001143 is an FDA 510(k) clearance for the RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER. This device is classified as a Catheter, Urological (antimicrobial) And Accessories (Class II - Special Controls, product code MJC).
Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on July 7, 2000, 88 days after receiving the submission on April 10, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K001143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2000 |
| Decision Date | July 07, 2000 |
| Days to Decision | 88 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 |