Cleared Traditional

K080806 - ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608

K080806 is an FDA 510(k) clearance for ANGIOJET ULTRA SPIROFLEX VG 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 14-day FDA review.

K080806 · Possis Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2008
Decision
14d
Days
Class 2
Risk

K080806 is an FDA 510(k) clearance for the ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608. 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 April 4, 2008 after a review of 14 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

FDA 510(k) Submission Details - K080806

510(k) Number K080806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2008
Decision Date April 04, 2008
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K080806.
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER,
K083784 · Vascular Solutions, Inc. · Mar 2009
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K082382 · Possis Medical, Inc. · Dec 2008
MODIFICATION TO FETCH ASPIRATION CATHETER
K081989 · Possis Medical, Inc. · Sep 2008
QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
K073519 · Kensey Nash Corp. · Mar 2008
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K073441 · Possis Medical, Inc. · Jan 2008