Clearance Summary
NEWCHILL(TM) CARDIAC INSULATOR received FDA 510(k) clearance under submission number K892804, sponsored by Acacia Laboratories, 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 1989-07-14.
- Submission: K892804
- Applicant / Sponsor: Acacia Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1989-07-14
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.