Clearance Summary
GENTLE HEADER received FDA 510(k) clearance under submission number K902845, sponsored by Enhanced Perfusion Systems, 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 1990-12-03.
- Submission: K902845
- Applicant / Sponsor: Enhanced Perfusion Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4390
- Decision date: 1990-12-03
Classification & Regulation
This clearance is catalogued under FDA product code DWE and 21 CFR 870.4390, within the Cardiovascular review panel as a Class II device.