Cleared Traditional

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

K183290 · Thrombolex, Inc. · Cardiovascular

Feb 2019

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K183290 is an FDA 510(k) clearance for the Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Thrombolex, Inc. (New Britain, US). The FDA issued a Cleared decision on February 25, 2019, 91 days after receiving the submission on November 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K183290 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2018
Decision Date	February 25, 2019
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEY — Mechanical Thrombolysis Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.