K950344 is an FDA 510(k) clearance for the HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER. This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II - Special Controls, product code FCM).
Submitted by Acacia Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 24, 1995, 56 days after receiving the submission on January 27, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K950344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | January 27, 1995 |
| Decision Date | March 24, 1995 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |