Clearance Summary
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES received FDA 510(k) clearance under submission number K112327, sponsored by Cardiac Assist, Maquet Cardiovascular, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-09-09.
- Submission: K112327
- Applicant / Sponsor: Cardiac Assist, Maquet Cardiovascular, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 2011-09-09
Classification & Regulation
This clearance is catalogued under FDA product code DSP and 21 CFR 870.3535, within the Cardiovascular review panel as a Class II device.