Cleared Traditional

K163356 - Pulse* Spray Infusion System

K163356 is an FDA 510(k) clearance for Pulse* Spray Infusion System, manufactured by AngioDynamics, Inc.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 181-day FDA review.

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

FDA 510(k) Submission Details - K163356

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.

QEY Device Classification - Class 2, Special Controls

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 46
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