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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 K870664
Device Name GUIDE WIRE
Applicant
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Applicant Contact SCHNEIDER, PHD
Correspondent
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Correspondent Contact SCHNEIDER, PHD
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/19/1987
Decision Date 03/25/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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