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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K001198
Device Name DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Applicant Contact JOANN WOLF
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Correspondent Contact JOANN WOLF
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/13/2000
Decision Date 05/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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