Not Cleared Post-NSE

DEN050006 - CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN050006 · Cardiomems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
80d
Days
Class 2
Risk

DEN050006 is an FDA 510(k) submission (not cleared) for the CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM. Classified as Sensor, Pressure, Aneurysm, Implantable (product code NQH), Class II - Special Controls.

Submitted by Cardiomems, Inc. (Atlanta, US). The FDA issued a Not Cleared (DENG) decision on October 28, 2005 after a review of 80 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2855 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Cardiomems, Inc. devices

Submission Details

510(k) Number DEN050006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 09, 2005
Decision Date October 28, 2005
Days to Decision 80 days
Submission Type Post-NSE
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics

Device Classification

Product Code NQH Sensor, Pressure, Aneurysm, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2855
Definition This Device Is Intended To Measure The Pressure In The Aneurysm Sac During And After An Endovascular Procedure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.