Cleared Traditional

K060092 - QUICKCAT EXTRACTION CATHETER

K060092 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 Traditional 510(k) pathway after a 56-day FDA review.

K060092 · Kensey Nash Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2006
Decision
56d
Days
Class 2
Risk

K060092 is an FDA 510(k) clearance for the QUICKCAT EXTRACTION CATHETER. 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 9, 2006 after a review of 56 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 Kensey Nash Corp. devices

FDA 510(k) Submission Details - K060092

510(k) Number K060092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2006
Decision Date March 09, 2006
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 71
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K060092.
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
K061951 · Possis Medical, Inc. · Nov 2006
FETCH ASPIRATION CATHETER
K062172 · Possis Medical, Inc. · Sep 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · Medtronic Vascular · Sep 2006
RIO ASPIRATION CATHETER
K051880 · Boston Scientific Corp · Jan 2006
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · Possis Medical, Inc. · Nov 2005
VASCULAR SOLUTIONS PRONTO V3 EXTRACTION CATHETER
K052232 · Vascular Solutions, Inc. · Sep 2005