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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K955785
Device Name TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
Applicant
C.R. BARD, INC.
12 ELIZABETH DR.
CHELMSFORD,  MA  01824
Applicant Contact ROBERT T MIRAGILUOLO
Correspondent
C.R. BARD, INC.
12 ELIZABETH DR.
CHELMSFORD,  MA  01824
Correspondent Contact ROBERT T MIRAGILUOLO
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/21/1995
Decision Date 03/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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