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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

K211061 is an FDA 510(k) premarket notification submitted by Thrombolex, Inc. for the device "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)". The FDA issued a decision of Substantially Equivalent on June 10, 2021. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. Thrombolex, Inc. has at least 5 other 510(k) clearances on record.

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)

FDA data resources