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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 K971034
Device Name USCI MAINSTAY GUIDING CATHETER
Applicant
C.R. Bard, Inc.
129 Concord Rd.
P.O. Box 566
Billerica,  MA  01821
Applicant Contact ANNE KULIS
Correspondent
C.R. Bard, Inc.
129 Concord Rd.
P.O. Box 566
Billerica,  MA  01821
Correspondent Contact ANNE KULIS
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/21/1997
Decision Date 05/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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