Clearance Summary
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case received FDA 510(k) clearance under submission number K163542, sponsored by Datascope Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-01-31.
- Submission: K163542
- Applicant / Sponsor: Datascope Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 2017-01-31
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.