510(k) K140241
K140241 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EDWARDS TRANSFEMORAL BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on July 3, 2014. The device falls under product code OZT (Balloon Aortic Valvuloplasty), a Class II device regulated under 21 CFR 870.1255. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2014
- Date Received
- January 30, 2014
- 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.