Clearance Summary
INSULATION PAD received FDA 510(k) clearance under submission number K896307, sponsored by Bio-Vascular, 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 1990-01-19.
- Submission: K896307
- Applicant / Sponsor: Bio-Vascular, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1990-01-19
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.