Clearance Summary
MODIFICATION TO: FOX PLUS PTA CATHETER received FDA 510(k) clearance under submission number K080264, sponsored by Abbott Vascular-Vascular Solutions. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-03-26.
- Submission: K080264
- Applicant / Sponsor: Abbott Vascular-Vascular Solutions
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2008-03-26
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.