Cleared Special

ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) (K042874) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042874 · Possis Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2004
Decision
18d
Days
Class 2
Risk

K042874 is an FDA 510(k) clearance for the ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX). Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Possis Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 5, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Possis Medical, Inc. devices

Submission Details

510(k) Number K042874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2004
Decision Date November 05, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 35
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K042874.
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · Cordis Corp. · Jun 1999
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
K990805 · Cordis Corp. · Mar 1999