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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 K903923
Device Name USCI(R) SILK (TM) GUIDE WIRE
Applicant
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Applicant Contact JANET BENSON
Correspondent
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Correspondent Contact JANET BENSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/24/1990
Decision Date 11/21/1990
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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