Cleared Traditional

LEADERFLEX

K141026 · Vygon · General Hospital

Jul 2014

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K141026 is an FDA 510(k) clearance for the LEADERFLEX, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Vygon (Lansdale Montgomery, US). The FDA issued a Cleared decision on July 30, 2014, 99 days after receiving the submission on April 22, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K141026 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2014
Decision Date	July 30, 2014
Days to Decision	99 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