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510(k) K193071

Bashir Plus Endovascular Catheter by Thrombolex, Inc. — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2019
Date Received
November 4, 2019
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)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • 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)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)