Cleared Special

K073519 - QUICKCAT EXTRACTION CATHETER

K073519 is an FDA 510(k) clearance for QUICKCAT EXTRACTION CATHETER, manufactured by Kensey Nash Corp.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 105-day FDA review.

K073519 · Kensey Nash Corp. · Cardiovascular device
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Mar 2008
Decision
105d
Days
Class 2
Risk

K073519 is an FDA 510(k) clearance for the QUICKCAT EXTRACTION CATHETER, MODEL 60090-01. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on March 28, 2008 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kensey Nash Corp. devices

FDA 510(k) Submission Details - K073519

510(k) Number K073519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date March 28, 2008
Days to Decision 105 days
Submission Type Special
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
Modification to existing cleared device.

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 71
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K073519.
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K082382 · Possis Medical, Inc. · Dec 2008
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
FLEXOR EVAC ASPIRATION CATHETER
K073627 · Cook, Inc. · Mar 2008
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
K073441 · Possis Medical, Inc. · Jan 2008
PRONTO LOW PROFILE (LP) EXTRACTION CATHETER, MODEL 5010
K072810 · Vascular Solutions, Inc. · Dec 2007