Cleared Traditional

pilot TLS

K241587 · Vygon Corporation · Cardiovascular
Feb 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K241587 is an FDA 510(k) clearance for the pilot TLS, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Vygon Corporation (Lansdale Montgomery, US). The FDA issued a Cleared decision on February 26, 2025, 268 days after receiving the submission on June 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K241587 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2024
Decision Date February 26, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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