Cleared Traditional

K192864 - UNI*FUSE Infusion System with Cooper Wire

K192864 is the FDA 510(k) clearance for UNI*FUSE Infusion System with Cooper Wire by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K192864 · AngioDynamics, Inc. · Cardiovascular device
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Jun 2020
Decision
238d
Days
Class 2
Risk

K192864 is an FDA 510(k) clearance for the UNI*FUSE 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 June 1, 2020 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K192864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2019
Decision Date June 01, 2020
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 29
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K192864.
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
K211061 · Thrombolex, Inc. · Jun 2021
UNIFUSE Infusion System with Cooper Wire
K202347 · AngioDynamics, Inc. · Sep 2020
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
K200648 · Ekos Corporation · Aug 2020
Bashir Plus Endovascular Catheter
K193071 · Thrombolex, Inc. · Dec 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · Thrombolex, Inc. · Oct 2019
EkoSonic Endovascular Device
K191119 · Btg International, Inc. · Aug 2019