Cleared Traditional

K071336 - ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOM...

K071336 is the FDA 510(k) clearance for ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOM... by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (product code QEZ) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K071336 · Possis Medical, Inc. · Cardiovascular device
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Aug 2007
Decision
105d
Days
Class 2
Risk

K071336 is an FDA 510(k) clearance for the ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307. 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 August 24, 2007 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Possis Medical, Inc. devices

Submission Details

510(k) Number K071336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2007
Decision Date August 24, 2007
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K071336.
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