Cleared Traditional

K082382 - ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039

K082382 is an FDA 510(k) clearance for ANGIOJET ULTRA AVX THROMBECTOMY SET, 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 115-day FDA review.

K082382 · Possis Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
115d
Days
Class 2
Risk

K082382 is an FDA 510(k) clearance for the ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039. 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 December 12, 2008 after a review of 115 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 - K082382

510(k) Number K082382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date December 12, 2008
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 K082382.
ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
K091593 · Possis Medical, Inc. · Jun 2009
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001
K090253 · Possis Medical, Inc. · Apr 2009
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
K083784 · Vascular Solutions, Inc. · Mar 2009
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · Possis Medical, Inc. · Sep 2008
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608
K080806 · Possis Medical, Inc. · Apr 2008
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
K073519 · Kensey Nash Corp. · Mar 2008