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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 K201489
Device Name Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
Applicant
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Applicant Contact Amy Clendening-Wheeler
Correspondent
Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens,  TX  75751
Correspondent Contact Amy Clendening-Wheeler
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
MMX  
Date Received06/04/2020
Decision Date 12/22/2020
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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