Cleared Traditional

K953384 - Multi Side Hole lnfusion System

K953384 is the FDA 510(k) clearance for Multi Side Hole lnfusion System by AngioDynamics, Inc.. It is a Class 2 Cardiovascular device (product code QEY) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K953384 · AngioDynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
156d
Days
Class 2
Risk

K953384 is an FDA 510(k) clearance for the Multi Side Hole lnfusion System. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 156 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 K953384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date December 22, 1995
Days to Decision 156 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 125d · This submission: 156d
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.