Cleared Traditional

KANEKA PHARMA AMERICA XPRESS-WAY RX

K101839 · Kaneka Pharma America, LLC · Cardiovascular

Oct 2010

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K101839 is an FDA 510(k) clearance for the KANEKA PHARMA AMERICA XPRESS-WAY RX, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Kaneka Pharma America, LLC (Hudson, US). The FDA issued a Cleared decision on October 22, 2010, 113 days after receiving the submission on July 1, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K101839 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2010
Decision Date	October 22, 2010
Days to Decision	113 days
Submission Type	Traditional
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.