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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
Applicant Contact DIANE DEPONTE-ARPINO
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004
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
Predetermined Change
Control Plan Authorized		 No
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