Cleared Special

BASHIR? .035 Endovascular Catheter, BASHIR? S-B .035 Endovascular Catheter

K231653 · Thrombolex, Inc. · Cardiovascular
Jul 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K231653 is an FDA 510(k) clearance for the BASHIR? .035 Endovascular Catheter, BASHIR? S-B .035 Endovascular Catheter, 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 July 3, 2023, 27 days after receiving the submission on June 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K231653 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2023
Decision Date July 03, 2023
Days to Decision 27 days
Submission Type Special
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.

Similar Devices — QEY Mechanical Thrombolysis Catheter

All 70
Versus? Catheter (VS110-9NB)
K260149 · Liquet Medical, Inc. · Feb 2026
VariFuse Adjustable Infusion Catheter
K251318 · Argon Medical Devices, Inc. · Jan 2026
Versus? Catheter (VS110-8B)
K241851 · Liquet Medical, Inc. · Nov 2024
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
K222095 · Thrombolex, Inc. · Apr 2023
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · Boston Scientific Corporation · Dec 2021

More from Thrombolex, Inc.

View all
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
K222095 · QEY · Apr 2023
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 · QEY · Jun 2021
Bashir Plus Endovascular Catheter
K193071 · QEY · Dec 2019
Bashir S-B Endovascular Catheter, Ref. No. 7101
K192598 · QEY · Oct 2019
Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
K183290 · QEY · Feb 2019