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Balloon Aortic Valvuloplasty

FDA product code OZT · 13 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1255
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-10-04 – 2026-05-06

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

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