510(k) K150343
K150343 is an FDA 510(k) premarket notification submitted by Intervalve, Inc. for the device "V8 Transluminal BAV Catheter". The FDA issued a decision of Substantially Equivalent on April 3, 2015. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255. Intervalve, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 2015
- Date Received
- February 11, 2015
- Clearance Type
- Special
- 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.