Clearance Summary
ENSTYLET MODELS EC0010, EC0020 received FDA 510(k) clearance under submission number K993376, 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 2000-01-05.
- Submission: K993376
- Applicant / Sponsor: Endocardial Solutions, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1380
- Decision date: 2000-01-05
Classification & Regulation
This clearance is catalogued under FDA product code DRB and 21 CFR 870.1380, within the Cardiovascular review panel as a Class II device.