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510(k) K211061

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) by Thrombolex, Inc. — Product Code QEY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 10, 2021
Date Received: April 9, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Mechanical Thrombolysis Catheter
Device Class: Class II
Regulation Number: 870.5150
Review Panel: CV
Submission Type

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

Other clearances by Thrombolex, Inc.

K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter (July 3, 2023)
K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
K193071 — Bashir Plus Endovascular Catheter (December 17, 2019)
K192598 — Bashir S-B Endovascular Catheter, Ref. No. 7101 (October 18, 2019)
K183290 — Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode (February 25, 2019)

Other clearances for product code QEY

K260149 — Versus Catheter (VS110-9NB) (February 17, 2026)
K251318 — VariFuse Adjustable Infusion Catheter (January 20, 2026)
K241851 — Versus Catheter (VS110-8B) (November 25, 2024)
K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter (July 3, 2023)
K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
K220866 — EKOS+ Endovascular Device (April 20, 2022)
K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device (December 14, 2021)
K211080 — EkoSonic Endovascular Device (November 19, 2021)
K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)
K200648 — EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (August 17, 2020)