Clearance Summary
CV PERI-GUARD AND VASCU-GUARD received FDA 510(k) clearance under submission number K983602, sponsored by Bio-Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-11-12.
- Submission: K983602
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 1998-11-12
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.