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510(k) K241587

pilot TLS by Vygon Corporation — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2025
Date Received
June 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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