Clearance Summary
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX received FDA 510(k) clearance under submission number K031636, sponsored by Datascope Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-08-11.
- Submission: K031636
- Applicant / Sponsor: Datascope Corp.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 2003-08-11
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.