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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K171348
Device Name Pinpoint GT Needle Guide Kits
Applicant
C.R. Bard, Inc.
650 N. 5600 W.
Salt Lake City,  UT  84116
Applicant Contact Christopher M. Phillips
Correspondent
C.R. Bard, Inc.
650 N. 5600 W.
Salt Lake City,  UT  84116
Correspondent Contact Christopher M. Phillips
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/08/2017
Decision Date 05/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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