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510(k) K190779

Trevo XP ProVue Retriever by Stryker — Product Code POL

K190779 is an FDA 510(k) premarket notification submitted by Stryker for the device "Trevo XP ProVue Retriever". The FDA issued a decision of Substantially Equivalent on June 25, 2019. 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. Stryker has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2019
Date Received
March 27, 2019
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 Stryker

  • K261481 — Pangea Femur Reconstruction System (June 29, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)
  • K250163 — T2 Alpha Femur Retrograde Nailing System (August 13, 2025)
  • K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pan (October 6, 2024)
  • K233919 — VariAx 2 Distal Radius System (March 25, 2024)
  • K233741 — Hoffmann LRF System (December 21, 2023)
  • K230045 — HipCheck (September 29, 2023)
  • K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with (September 20, 2023)

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)
  • 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)

FDA data resources