Clearance Summary
ANGIOMAT ILLUMENA received FDA 510(k) clearance under submission number K963071, sponsored by Mallinckrodt Inc., Liebel-Flarsheim Business. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-09-23.
- Submission: K963071
- Applicant / Sponsor: Mallinckrodt Inc., Liebel-Flarsheim Business
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1997-09-23
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.