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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K172458
Device Name HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Applicant
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Applicant Contact Mikael Evans
Correspondent
Smiths Medical Asd, Inc.
6000 Nathan Ln. N
Plymouth,  MN  55442
Correspondent Contact Mikael Evans
Regulation Number870.2850
Classification Product Code
DRS  
Date Received08/14/2017
Decision Date 11/09/2017
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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