Cleared Traditional

BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

K211061 · Thrombolex, Inc. · Cardiovascular

Jun 2021

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K211061 is an FDA 510(k) clearance for the BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240), 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 June 10, 2021, 62 days after receiving the submission on April 9, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K211061 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2021
Decision Date	June 10, 2021
Days to Decision	62 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.