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510(k) K231653

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter by Thrombolex, Inc. — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2023
Date Received
June 6, 2023
Clearance Type
Special
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.

  • K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • 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)
  • 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)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 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)