Cleared Special

UNIFUSE Infusion System with Cooper Wire

K202347 · AngioDynamics, Inc. · Cardiovascular
Sep 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K202347 is an FDA 510(k) clearance for the UNIFUSE Infusion System with Cooper Wire, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 15, 2020, 28 days after receiving the submission on August 18, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K202347 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2020
Decision Date September 15, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEY — Mechanical Thrombolysis Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.

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