CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080

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 S2 Pressure Sensor With Delivery System, Model S2-2080.

Pre-market Notification Details

Device IDK082191
510k NumberK082191
Device Name:CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
ClassificationSensor, Pressure, Aneurysm, Implantable
Applicant CARDIOMEMS INC 387 TECHNOLOGY CIRCLE, NW SUITE 500 Atlanta,  GA  30313
ContactGrace Powers
CorrespondentGrace Powers
CARDIOMEMS INC 387 TECHNOLOGY CIRCLE, NW SUITE 500 Atlanta,  GA  30313
Product CodeNQH  
CFR Regulation Number870.2855 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-04
Decision Date2008-08-19
Summary:summary

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