Clearance Summary
EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA received FDA 510(k) clearance under submission number K980631, sponsored by Embol-X, 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 1999-02-02.
- Submission: K980631
- Applicant / Sponsor: Embol-X, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 1999-02-02
Classification & Regulation
This clearance is catalogued under FDA product code DXC and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.