Cleared Traditional

K950907 - PULSE*SPRAY INFUSION SYSTEM (FDA 510(k) Clearance)

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

K950907 · Angiodynamics, Div. E-Z-Em, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
93d
Days
Class 2
Risk

K950907 is an FDA 510(k) clearance for the PULSE*SPRAY INFUSION SYSTEM. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Angiodynamics, Div. E-Z-Em, Inc. (Queensbury, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 93 days - within the typical 510(k) review window.

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, Div. E-Z-Em, Inc. devices

Submission Details

510(k) Number K950907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date May 17, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
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 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K950907.
Versus™ Catheter (VS110-9NB)
K260149 · Liquet Medical, Inc. · Feb 2026
VariFuse Adjustable Infusion Catheter
K251318 · Argon Medical Devices, Inc. · Jan 2026
Versus™ Catheter (VS110-8B)
K241851 · Liquet Medical, Inc. · Nov 2024
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
K231653 · Thrombolex, Inc. · Jul 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
K222095 · Thrombolex, Inc. · Apr 2023
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022