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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 K925074
Device Name USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING
Applicant
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Applicant Contact CHRISTINE ERICKSON
Correspondent
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Correspondent Contact CHRISTINE ERICKSON
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/07/1992
Decision Date 03/01/1993
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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