510(k) K070448
K070448 is an FDA 510(k) premarket notification submitted by Cardiomems, Inc. for the device "CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001". The FDA issued a decision of Substantially Equivalent on March 15, 2007. 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
- March 15, 2007
- Date Received
- February 15, 2007
- 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.