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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 K241587
Device Name pilot TLS
Applicant
Vygon Corporation
2750 Morris Road
Suite A200
Lansdale Montgomery,  PA  19446
Applicant Contact Chris Steinke
Correspondent
Vygon Corporation
2750 Morris Road
Suite A200
Lansdale Montgomery,  PA  19446
Correspondent Contact Chris Steinke
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/03/2024
Decision Date 02/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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