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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 K230631
Device Name Kodiak™ Dual Port Coaxial Introducer Kit
Applicant
Argon Medical Devices
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Pratusha Kudumula
Correspondent
Argon Medical Devices
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Pratusha Kudumula
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/07/2023
Decision Date 05/22/2023
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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