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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 K213638
Device Name Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)
Applicant
Argon Medical Devices
1445 Flat Creek Road
Athens,  TX  75751
Applicant Contact Ana Jimenez-Hughes
Correspondent
Argon Medical Devices
1445 Flat Creek Road
Athens,  TX  75751
Correspondent Contact Ana Jimenez-Hughes
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/18/2021
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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