Cleared Special

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

K121301 is the FDA 510(k) clearance for XPRESSWAY RX CATHETER (6F LD-VERISON) by Kaneka Pharma America, LLC. It is a Class 2 Cardiovascular device (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.

View all Kaneka Pharma America, LLC devices

Submission Details

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.

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 51
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K121301.
Merit ASAPLP Aspiration Catheter
K132155 · Merit Medical Systems, Inc. · Nov 2013
EXPORT ADVANCE ASPIRATION CATHETER
K130536 · Medtronic, Inc. · Jul 2013
REFLOW ASPIRATION CATHETER
K123482 · Volcano Corporation · Apr 2013
EXPORT XT CATHETER, EXPORT AP CATHETER
K120808 · Medtronic, Inc. · Jun 2012
ANGIOJET SOLENT DISTA THROMBECTOMY SET
K113363 · Medrad, Inc. · Jun 2012
ANGIOJET ULTRA DVX THROMBECTOMY SET
K113428 · Medrad, Inc. · Dec 2011