Clearance Summary
ENSITE 3000 SYSTEM received FDA 510(k) clearance under submission number K983456, sponsored by Endocardial Solutions, 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 1999-04-21.
- Submission: K983456
- Applicant / Sponsor: Endocardial Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 1999-04-21
Classification & Regulation
This clearance is catalogued under FDA product code MTD and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.