Clearance Summary
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 received FDA 510(k) clearance under submission number K010471, sponsored by Irvine Biomedical, 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 2001-06-06.
- Submission: K010471
- Applicant / Sponsor: Irvine Biomedical, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2001-06-06
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.