Cleared Special

XPRESSWAY RX CATHETER (6F LD-VERISON)

K121301 · Kaneka Pharma America, LLC · Cardiovascular

Jul 2012

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K121301 is an FDA 510(k) clearance for the XPRESSWAY RX CATHETER (6F LD-VERISON), a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on July 30, 2012, 90 days after receiving the submission on May 1, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K121301 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.