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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 K855103
Device Name CIRIBART GYUDUBG CATGETER
Applicant
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact BRUCE BEAUCHEMIN
Correspondent
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact BRUCE BEAUCHEMIN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/23/1985
Decision Date 02/18/1986
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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