Cleared Traditional

Leaderflex Mini and Leaderflex Nano

K212370 · Vygon USA · General Hospital

Aug 2022

Decision

395d

Days

Class 2

Risk

About This 510(k) Submission

K212370 is an FDA 510(k) clearance for the Leaderflex Mini and Leaderflex Nano, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Vygon USA (Lansdale Montgomery, US). The FDA issued a Cleared decision on August 29, 2022, 395 days after receiving the submission on July 30, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K212370 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 2021
Decision Date	August 29, 2022
Days to Decision	395 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200