510(k) K121083
K121083 is an FDA 510(k) premarket notification submitted by Loma Vista Medical for the device "TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA". The FDA issued a decision of Substantially Equivalent on October 11, 2012. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2012
- Date Received
- April 10, 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.