Clearance Summary
GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS received FDA 510(k) clearance under submission number K040010, sponsored by Genesis Medical Interventional, 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 2004-07-19.
- Submission: K040010
- Applicant / Sponsor: Genesis Medical Interventional, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2004-07-19
Classification & Regulation
This clearance is catalogued under FDA product code QEW and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.