Clearance Summary
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES received FDA 510(k) clearance under submission number K980385, sponsored by Datascope Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-05-01.
- Submission: K980385
- Applicant / Sponsor: Datascope Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 1998-05-01
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.