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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, balloon, intra-aortic and control
510(k) Number K031569
Device Name DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Applicant Contact JOANN TAYLOR
Correspondent
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Correspondent Contact JOANN TAYLOR
Regulation Number870.3535
Classification Product Code
DSP  
Date Received05/20/2003
Decision Date 06/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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