K122012 is an FDA 510(k) clearance for the Z-MED Z-MED II. This device is classified as a Balloon Aortic Valvuloplasty (Class II - Special Controls, product code OZT).
Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 4, 2012, 86 days after receiving the submission on July 10, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1255. A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve..
| 510(k) Number | K122012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2012 |
| Decision Date | October 04, 2012 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OZT — Balloon Aortic Valvuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1255 |
| Definition | A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve. |