Clearance Summary
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582 received FDA 510(k) clearance under submission number K051096, sponsored by St. Jude Medical, Daig Division, 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 2005-05-17.
- Submission: K051096
- Applicant / Sponsor: St. Jude Medical, Daig Division, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2005-05-17
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.