Cleared Traditional

K080806 - ANGIOJET ULTRA SPIROFLEX VG THROMBECTOM...

K080806 is the FDA 510(k) clearance for ANGIOJET ULTRA SPIROFLEX VG THROMBECTOM... by Possis Medical, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

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
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