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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K230669
Device Name L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
Applicant
Argon Medical Devices
1445 Flat Creek Rd.
Athens,  TX  75751
Applicant Contact Scott Bishop
Correspondent
Argon Medical Devices
1445 Flat Creek Rd.
Athens,  TX  75751
Correspondent Contact Scott Bishop
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
FOZ  
Date Received03/10/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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