Cleared Special

K042874 - ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)

K042874 is an FDA 510(k) clearance for ANGIOJET XMI CATHETER - RAPID EXCHANGE ..., manufactured by Possis Medical, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 18-day FDA review.

K042874 · Possis Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K042874

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

QEZ Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K042874.
MODIFICATION TO: EXPORT CATHETER
K050139 · Medtronic Vascular · Mar 2005
DIVER C.E. CATHETER
K050276 · Invatec Innovative Technologies, S.R.L. · Mar 2005
MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K042937 · Vascular Solutions, Inc. · Jan 2005
EXPORT CATHETER
K040869 · Medtronic Vascular · Jun 2004
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
K040013 · Possis Medical, Inc. · May 2004
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · Vascular Solutions, Inc. · Dec 2003
K042874 · ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)
Download PDF FDA Summary Possis Medical, Inc.