Cleared Traditional

K071336 - ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307

K071336 is an FDA 510(k) clearance for ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOM..., manufactured by Possis Medical, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K071336

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
Combination Product No
PCCP Authorized No
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.

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 73
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K071336.
ANGIOJET ULTRA
K072769 · Possis Medical, Inc. · Nov 2007
QXT EXTRACTION CATHETER
K071727 · Vascular Solutions, Inc. · Sep 2007
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552
K072269 · Possis Medical, Inc. · Sep 2007
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
K071342 · Possis Medical, Inc. · Jul 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071514 · Possis Medical, Inc. · Jul 2007
PRONTO .035 EXTRACTION CATHETER
K070403 · Vascular Solutions, Inc. · Jun 2007