Clearance Summary
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM received FDA 510(k) clearance under submission number K022640, sponsored by Bacchus Vascular, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-12-02.
- Submission: K022640
- Applicant / Sponsor: Bacchus Vascular, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4875
- Decision date: 2002-12-02
Classification & Regulation
This clearance is catalogued under FDA product code MCW and 21 CFR 870.4875, within the Cardiovascular review panel as a Class II device.