Clearance Summary
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 received FDA 510(k) clearance under submission number K082191, sponsored by Cardiomems, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-08-19.
- Submission: K082191
- Applicant / Sponsor: Cardiomems, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2855
- Decision date: 2008-08-19
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.