Cleared Special

K121301 - XPRESSWAY RX CATHETER (6F LD-VERISON)

K121301 is an FDA 510(k) clearance for XPRESSWAY RX CATHETER (6F LD-VERISON), manufactured by Kaneka Pharma America, LLC. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 90-day FDA review.

K121301 · Kaneka Pharma America, LLC · Cardiovascular device
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Jul 2012
Decision
90d
Days
Class 2
Risk

K121301 is an FDA 510(k) clearance for the XPRESSWAY RX CATHETER (6F LD-VERISON). Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on July 30, 2012 after a review of 90 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 - K121301

510(k) Number K121301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2012
Decision Date July 30, 2012
Days to Decision 90 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 95
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K121301.
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
REFLOW ASPIRATION CATHETER
K123482 · Volcano Corporation · Apr 2013
CLEARLUMEN THROMBECTOMY SYSTEM
K120508 · Walk Vascular, LLC · Nov 2012
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · Medrad, Inc. · Jun 2012
ASPIRE MAX ASPIRATION CATHETER
K113757 · Control Medical Technology, LLC · Feb 2012
K121301 · XPRESSWAY RX CATHETER (6F LD-VERISON)
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