Cleared Special

K202347 - UNIFUSE Infusion System with Cooper Wire (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K202347 is an FDA 510(k) clearance for the UNIFUSE Infusion System with Cooper Wire. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 15, 2020 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K202347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEY Mechanical Thrombolysis Catheter

All 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K202347.
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Versus™ Catheter (VS110-8B)
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EkoSonic Endovascular Device, EKOS+ Endovascular Device
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EkoSonic Endovascular Device
K211080 · Boston Scientific · Nov 2021