Cleared Traditional

K953384 - Multi Side Hole lnfusion System (FDA 510(k) Clearance)

K953384 · AngioDynamics, Inc. · Cardiovascular device
Dec 1995
Decision
156d
Days
Class 2
Risk

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

Submitted by AngioDynamics, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 22, 1995, 156 days after receiving the submission on July 19, 1995.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature..

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

Device Classification

Product Code QEY — Mechanical Thrombolysis Catheter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.