Clearance Summary
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE received FDA 510(k) clearance under submission number K062531, sponsored by Cordis Corp., A Johnson & Johnson Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-09-22.
- Submission: K062531
- Applicant / Sponsor: Cordis Corp., A Johnson & Johnson Co.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2006-09-22
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.