Clearance Summary
EMBOL-X INTRODUCER, MODEL CF00200 received FDA 510(k) clearance under submission number K002973, 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 2001-04-26.
- Submission: K002973
- Applicant / Sponsor: Embol-X, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2001-04-26
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.