CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001

Sensor, Pressure, Aneurysm, Implantable

CARDIOMEMS INC

The following data is part of a premarket notification filed by Cardiomems Inc with the FDA for Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model Ads-1001.

Pre-market Notification Details

Device IDK070448
510k NumberK070448
Device Name:CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
ClassificationSensor, Pressure, Aneurysm, Implantable
Applicant CARDIOMEMS INC 75 FIFTH ST., NW SUITE 440 Atlanta,  GA  30308
ContactGrace Powers
CorrespondentGrace Powers
CARDIOMEMS INC 75 FIFTH ST., NW SUITE 440 Atlanta,  GA  30308
Product CodeNQH  
CFR Regulation Number870.2855 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-15
Decision Date2007-03-15
Summary:summary

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