510(k) K082191
K082191 is an FDA 510(k) premarket notification submitted by Cardiomems, Inc. for the device "CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080". The FDA issued a decision of Substantially Equivalent on August 19, 2008. The device falls under product code NQH (Sensor, Pressure, Aneurysm, Implantable), a Class II device regulated under 21 CFR 870.2855. Cardiomems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2008
- Date Received
- August 4, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sensor, Pressure, Aneurysm, Implantable
- Device Class
- Class II
- Regulation Number
- 870.2855
- Review Panel
- CV
- Submission Type
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.