Clearance Summary
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER received FDA 510(k) clearance under submission number K120868, sponsored by Datascope Corp., Cardiac Assist Division. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-04-20.
- Submission: K120868
- Applicant / Sponsor: Datascope Corp., Cardiac Assist Division
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 2012-04-20
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.