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510(k) K203358

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

K203358 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Solitaire X Revascularization Device". The FDA issued a decision of Substantially Equivalent on March 1, 2021. The device falls under product code POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment), a Class II device regulated under 21 CFR 882.5600. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2021
Date Received
November 16, 2020
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

  • K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Ri (January 2, 2025)
  • K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing (December 2, 2024)
  • 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)
  • 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)
  • K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (July 21, 2020)
  • K201689 — Riptide Aspiration System (July 21, 2020)

Other clearances for product code POL

  • K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device (February 28, 2025)
  • 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)
  • 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)
  • K190779 — Trevo XP ProVue Retriever (June 25, 2019)

FDA data resources