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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 K070448
Device Name CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
Applicant
Cardiomems, Inc.
75 Fifth St., NW
Suite 440
Atlanta,  GA  30308
Applicant Contact GRACE POWERS
Correspondent
Cardiomems, Inc.
75 Fifth St., NW
Suite 440
Atlanta,  GA  30308
Correspondent Contact GRACE POWERS
Regulation Number870.2855
Classification Product Code
NQH  
Date Received02/15/2007
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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