Cleared Traditional

Pulse* Spray Infusion System, Uni*Fuse Infusion System (K163356) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163356 · AngioDynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
181d
Days
Class 2
Risk

K163356 is an FDA 510(k) clearance for the Pulse* Spray Infusion System, Uni*Fuse Infusion System. 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 May 30, 2017 after a review of 181 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 K163356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 27
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K163356.
EkoSonic Endovascular Device with Control Unit 4.0
K183361 · Btg International, Inc. · Apr 2019
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
K183290 · Thrombolex, Inc. · Feb 2019
EkoSonic Endovascular System
K182324 · Btg International, Inc. · Nov 2018
SpeedLyser Infusion Catheter Kit
K170258 · AngioDynamics, Inc. · Feb 2017
Squirt Fluid Delivery System
K162777 · Merit Medical Systems, Inc. · Oct 2016
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
K130904 · Covidien · Oct 2013