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510(k) DEN150049

Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm by Concentric Medical, Inc. — Product Code POL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 2, 2016
Date Received
October 26, 2015
Clearance Type
Direct
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 Concentric Medical, Inc.

  • K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (February 15, 2018)
  • K153729 — 8F FlowGate2 Balloon Guide Catheter (January 27, 2016)
  • K150616 — Trevo XP ProVue Retriever (4x30mm) (June 12, 2015)
  • K143077 — Trevo XP ProVue Retriever (6X25mm) (April 6, 2015)
  • K133177 — MODIFIED HD GUIDE CATHETER (February 25, 2014)
  • K133464 — MODIFIED TREVO PROVUE RETRIEVER (January 17, 2014)
  • K132641 — MODIFIED TREVO PROVUE RETRIEVER (January 13, 2014)
  • K131437 — MODIFIED CONCENTRIC MICROCATHETER (October 11, 2013)
  • K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER (October 3, 2013)
  • K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 (November 21, 2012)

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)