Clearance Summary
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM received FDA 510(k) clearance under submission number K961924, sponsored by Irvine Biomedical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-04-11.
- Submission: K961924
- Applicant / Sponsor: Irvine Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1997-04-11
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.