510(k) DEN080015
DEN080015 is an FDA 510(k) premarket notification submitted by NuMED, Inc. for the device "NUCLEUS-X PTV CATHETER". The FDA issued a decision of De Novo Granted on June 11, 2012. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255. NuMED, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 11, 2012
- Date Received
- December 24, 2008
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Balloon Aortic Valvuloplasty
- Device Class
- Class II
- Regulation Number
- 870.1255
- Review Panel
- CV
- Submission Type
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.