Cleared Special

K033443 - SPEEDLYSER INFUSION CATHETER KIT (FDA 510(k) Clearance)

K033443 · AngioDynamics, Inc. · Cardiovascular device
Nov 2003
Decision
21d
Days
Class 2
Risk

K033443 is an FDA 510(k) clearance for the SPEEDLYSER INFUSION CATHETER KIT. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on November 19, 2003, 21 days after receiving the submission on October 29, 2003.

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 K033443 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 29, 2003
Decision Date November 19, 2003
Days to Decision 21 days
Submission Type Special
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.