Cleared Traditional

BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101

K222095 · Thrombolex, Inc. · Cardiovascular

Apr 2023

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K222095 is an FDA 510(k) clearance for the BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101, 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 April 20, 2023, 276 days after receiving the submission on July 18, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K222095 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2022
Decision Date	April 20, 2023
Days to Decision	276 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.