Clearance Summary
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 received FDA 510(k) clearance under submission number K090613, sponsored by St. Jude Medical, Cardiac Rhythm Management Divisi. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-07-01.
- Submission: K090613
- Applicant / Sponsor: St. Jude Medical, Cardiac Rhythm Management Divisi
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2009-07-01
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.