Clearance Summary
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION received FDA 510(k) clearance under submission number K940231, 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 1994-09-13.
- Submission: K940231
- Applicant / Sponsor: Datascope Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 1994-09-13
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.