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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 K960166
Device Name PERCOR STAT-DL 9.5 FR. 34 & 40CC
Applicant
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Applicant Contact DIANE DEPONTE-ARPINO
Correspondent
DATASCOPE CORP.
15 LAW DR.
FAIRFIELD,  NJ  07004 -3206
Correspondent Contact DIANE DEPONTE-ARPINO
Regulation Number870.3535
Classification Product Code
DSP  
Date Received01/16/1996
Decision Date 04/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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