Home / 510(k) Clearances / DEN050006

510(k) DEN050006

CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM by Cardiomems, Inc. — Product Code NQH

DEN050006 is an FDA 510(k) premarket notification submitted by Cardiomems, Inc. for the device "CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM". The FDA issued a decision of De Novo Granted on October 28, 2005. 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
DENG (De Novo Granted)
Decision Date
October 28, 2005
Date Received
August 9, 2005
Clearance Type
Post-NSE
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.

Other clearances by Cardiomems, Inc.

  • K082191 — CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (August 19, 2008)
  • K070680 — CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2 (April 5, 2007)
  • K070448 — CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (March 15, 2007)
  • K061046 — CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INT (October 12, 2006)

Other clearances for product code NQH

  • K082191 — CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (August 19, 2008)
  • K070680 — CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2 (April 5, 2007)
  • K070448 — CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (March 15, 2007)
  • K061046 — CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INT (October 12, 2006)

FDA data resources