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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K973007
Device Name DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004
Applicant Contact WHITNEY TORNING
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004
Correspondent Contact WHITNEY TORNING
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/13/1997
Decision Date 11/06/1997
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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