Cleared Traditional

K071342 - ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET

K071342 is the FDA 510(k) clearance for ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K071342 · Possis Medical, Inc. · Cardiovascular device
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Jul 2007
Decision
78d
Days
Class 2
Risk

K071342 is an FDA 510(k) clearance for the ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 10504.... 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 July 31, 2007 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Possis Medical, Inc. devices

Submission Details

510(k) Number K071342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2007
Decision Date July 31, 2007
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 49
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K071342.
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
K072810 · Vascular Solutions, Inc. · Dec 2007
QXT EXTRACTION CATHETER
K071727 · Vascular Solutions, Inc. · Sep 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007
PRONTO V3 EXTRACTION CATHETER, MODEL 5003
K063371 · Vascular Solutions, Inc. · Dec 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006