DEN080015 is an FDA 510(k) submission for the NUCLEUS-X PTV CATHETER. 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 Not Cleared (DENG) decision on June 11, 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 | DEN080015 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 24, 2008 |
| Decision Date | June 11, 2012 |
| Days to Decision | 1265 days |
| Submission Type | Post-NSE |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| 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. |