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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Oximeter, Fiber-Optic
510(k) Number K140129
Device Name PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
Applicant
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Applicant Contact KRISTIN CASPER
Correspondent
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Correspondent Contact KRISTIN CASPER
Regulation Number870.1230
Classification Product Code
DQE  
Date Received01/16/2014
Decision Date 07/02/2014
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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