Cleared Traditional

K073441 - ANGIOJET ULTRA AVX THROMBECTOMY SET

K073441 is the FDA 510(k) clearance for ANGIOJET ULTRA AVX 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 48-day FDA review.

K073441 · Possis Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2008
Decision
48d
Days
Class 2
Risk

K073441 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 January 24, 2008 after a review of 48 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 K073441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2007
Decision Date January 24, 2008
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 K073441.
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K072810 · Vascular Solutions, Inc. · Dec 2007
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