The following data is part of a De Novo classification by Numed, Inc. with the FDA for Nucleus-x Ptv Catheter.
| DeNovo ID | DEN080015 |
| Device Name: | NUCLEUS-X PTV CATHETER |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | NUMED, INC. 2880 Main St. Hopkinton, NY 12965 |
| Contact | Nichelle Laflesh |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K082776 |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Post-NSE |
| Date Received | 2008-12-24 |
| Decision Date | 2012-06-11 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046964340345 | DEN080015 | 000 |
| 04046964340024 | DEN080015 | 000 |
| 04046964340048 | DEN080015 | 000 |
| 04046964340062 | DEN080015 | 000 |
| 04046964340086 | DEN080015 | 000 |
| 04046964340109 | DEN080015 | 000 |
| 04046964340123 | DEN080015 | 000 |
| 04046964340147 | DEN080015 | 000 |
| 04046964340161 | DEN080015 | 000 |
| 04046964340185 | DEN080015 | 000 |
| 04046964340208 | DEN080015 | 000 |
| 04046964340222 | DEN080015 | 000 |
| 04046964340246 | DEN080015 | 000 |
| 04046964340277 | DEN080015 | 000 |
| 04046964340291 | DEN080015 | 000 |
| 04046964340307 | DEN080015 | 000 |
| 04046964340321 | DEN080015 | 000 |
| 04046964340000 | DEN080015 | 000 |