510(k) K173352

Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) by Concentric Medical, Inc. — Product Code POL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 15, 2018
Date Received: October 25, 2017
Clearance Type: Traditional
Expedited Review: Yes
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.

DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProV (September 2, 2016)
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)