Clearance Summary
ADROIT GUIDING CATHETER received FDA 510(k) clearance under submission number K131225, sponsored by Cordis Corp., A Johnson & Johnson Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-05-29.
- Submission: K131225
- Applicant / Sponsor: Cordis Corp., A Johnson & Johnson Co.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2013-05-29
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.