Clearance Summary
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS received FDA 510(k) clearance under submission number K892856, 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 1989-11-08.
- Submission: K892856
- Applicant / Sponsor: Acacia Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1989-11-08
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.