K941012 is an FDA 510(k) clearance for the LOW PRESSURE TAMPONADE BALLOON CATHETER. This device is classified as a Catheter, Ureteral, Gastro-urology (Class II - Special Controls, product code EYB).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on April 18, 1994, 46 days after receiving the submission on March 3, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K941012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1994 |
| Decision Date | April 18, 1994 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EYB — Catheter, Ureteral, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |