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510(k) K162539

Solitaire 2 Revascularization Device by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code POL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2016
Date Received
September 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device Class
Class II
Regulation Number
882.5600
Review Panel
NE
Submission Type

A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

Other clearances by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

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  • K243080 — Riptide Aspiration System (October 29, 2024)
  • K211990 — Rist 071 Radial Access Guide Catheter (July 27, 2021)
  • K203432 — Axium Detachable Coil; Axium Prime Detachable Coil (July 7, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • K202850 — Concerto Versa, Detachable Coil (February 9, 2021)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K202318 — Marathon Flow Directed Micro Catheter (September 14, 2020)
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Other clearances for product code POL

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  • K231539 — pRESET LITE Thrombectomy Device (October 21, 2023)
  • K223305 — Trevo NXT ProVue Retriever (March 29, 2023)
  • K222848 — pRESET Thrombectomy Device (January 20, 2023)
  • K210502 — Trevo NXT ProVue Retriever (August 27, 2021)
  • K203358 — Solitaire X Revascularization Device (March 1, 2021)
  • K203219 — Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (December 29, 2020)
  • K193576 — Solitaire Platinum Revascularization Device, Solitaire X Revascularization Devic (November 20, 2020)
  • K200117 — Trevo NXT ProVue Retriever (February 7, 2020)
  • K192207 — Trevo NXT ProVue Retriever (November 22, 2019)