Clearance Summary
VASCU-CARE ANGIOSCOPE received FDA 510(k) clearance under submission number K880927, sponsored by Vascu-Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-05-16.
- Submission: K880927
- Applicant / Sponsor: Vascu-Care, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1988-05-16
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.