Clearance Summary
ReVive PV (Peripheral Vasculature) Thrombectomy Device received FDA 510(k) clearance under submission number K132281, sponsored by Codman & Shurtleff, 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 2013-08-30.
- Submission: K132281
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 2013-08-30
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.