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510(k) K241145

TLAB® Transvenous Liver Biopsy System (TF-18C) by Argon Medical Devices, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2024
Date Received
April 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (September 7, 2023)

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  • K252227 — Pounce(TM) Sheath (September 24, 2025)