Cleared Special

K073519 - QUICKCAT EXTRACTION CATHETER, MODEL 60090-01

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 94
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