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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 K142445
Device Name PINPOINT GT SAFETY INTRODUCER NEEDLE
Applicant
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact AMY MCMANUS
Correspondent
C.R. BARD, INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact AMY MCMANUS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/02/2014
Decision Date 04/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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