K945258 is an FDA 510(k) clearance for the CATCO URINARY COLLECTION KIT. This device is classified as a Urinary Drainage Collection Kit, For Indwelling Catheter (Class II - Special Controls, product code FCN).
Submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 16, 1995, 111 days after receiving the submission on October 28, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K945258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | October 28, 1994 |
| Decision Date | February 16, 1995 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCN — Urinary Drainage Collection Kit, For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |