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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sensor, Pressure, Aneurysm, Implantable
510(k) Number K061046
Device Name CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
Applicant
Cardiomems, Inc.
75 Fifth St., NW
Suite 440
Atlanta,  GA  30308
Applicant Contact CAROL VIERLING
Correspondent
Cardiomems, Inc.
75 Fifth St., NW
Suite 440
Atlanta,  GA  30308
Correspondent Contact CAROL VIERLING
Regulation Number870.2855
Classification Product Code
NQH  
Date Received04/14/2006
Decision Date 10/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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