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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 K951109
Device Name C-THRU CORONARY GUIDE WIRE
Applicant
Schneider (Europe) GmbH
Ackerstrasse 6
Bulach,  SE CH-8081
Correspondent
Schneider (Europe) GmbH
Ackerstrasse 6
Bulach,  SE CH-8081
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/10/1995
Decision Date 06/08/1995
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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