Clearance Summary
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM received FDA 510(k) clearance under submission number K133569, sponsored by Bard Peripheral Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-12-20.
- Submission: K133569
- Applicant / Sponsor: Bard Peripheral Vascular, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1255
- Decision date: 2013-12-20
Classification & Regulation
This clearance is catalogued under FDA product code OZT and 21 CFR 870.1255, within the Cardiovascular review panel as a Class II device.