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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K884502
Device Name USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
Applicant
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Applicant Contact JANICE PIASECKI
Correspondent
C.R. Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Correspondent Contact JANICE PIASECKI
Regulation Number870.1200
Classification Product Code
DQO  
Date Received10/26/1988
Decision Date 01/18/1989
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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