K951443 is an FDA 510(k) clearance for the STANDARD FOLEY SYSTEM PAK. This device is classified as a Urinary Drainage Collection Kit, For Indwelling Catheter (Class II - Special Controls, product code FCN).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on June 15, 1995, 78 days after receiving the submission on March 29, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K951443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1995 |
| Decision Date | June 15, 1995 |
| Days to Decision | 78 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 |