Clearance Summary
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM received FDA 510(k) clearance under submission number DEN050006, sponsored by Cardiomems, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2005-10-28.
- Submission: DEN050006
- Applicant / Sponsor: Cardiomems, Inc.
- Clearance pathway: Post-NSE
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2855
- Decision date: 2005-10-28
Classification & Regulation
This clearance is catalogued under FDA product code NQH and 21 CFR 870.2855, within the Cardiovascular review panel as a Class II device.