510(k) K123111
K123111 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 January 31, 2013. 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
- January 31, 2013
- Date Received
- October 3, 2012
- Clearance Type
- Traditional
- 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.