K022823 is an FDA 510(k) clearance for the VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520. This device is classified as a Valvulotome (Class II - Special Controls, product code MGZ).
Submitted by Geister Medizin Technik GmbH (Hot Springs, US). The FDA issued a Cleared decision on July 1, 2004, 675 days after receiving the submission on August 26, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4885.
| 510(k) Number | K022823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2002 |
| Decision Date | July 01, 2004 |
| Days to Decision | 675 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MGZ - Valvulotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4885 |