Clearance Summary
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 received FDA 510(k) clearance under submission number K061046, sponsored by Cardiomems, 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 2006-10-12.
- Submission: K061046
- Applicant / Sponsor: Cardiomems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2855
- Decision date: 2006-10-12
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.