Cleared Traditional

Pulse* Spray Infusion System, Uni*Fuse Infusion System

K163356 · AngioDynamics, Inc. · Cardiovascular

May 2017

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K163356 is an FDA 510(k) clearance for the Pulse* Spray Infusion System, Uni*Fuse Infusion System, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 30, 2017, 181 days after receiving the submission on November 30, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K163356 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2016
Decision Date	May 30, 2017
Days to Decision	181 days
Submission Type	Traditional
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.