Clearance Summary
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire received FDA 510(k) clearance under submission number K220654, sponsored by Cordis Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-04-06.
- Submission: K220654
- Applicant / Sponsor: Cordis Corporation
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2022-04-06
Classification & Regulation
This clearance is catalogued under FDA product code NTE and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.