Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm— 510(k) DEN150049

Name: FDA 510(k) clearance DEN150049
Creator: U.S. Food and Drug Administration
Published: 2016-09-02

Unknown

Concentric Medical, Inc.

FDA 510(k) clearance DEN150049 for Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm, Unknown on 2016-09-02. Applicant: Concentric Medical, Inc.. Device class: 2.

Clearance details

Applicant: Concentric Medical, Inc.
Product code: Code POL
Device class: Class 2
Regulation: 21 CFR 882.5600
Advisory panel: Neurology
Date received: 2015-10-26
Decision date: 2016-09-02
Decision: Unknown
Clearance type: Direct
Location: Mountain View, CA, US

View on FDA.gov ↗

Recent devices under product code POL

view all

K242676 — pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device2025-02-28
K231539 — pRESET LITE Thrombectomy Device2023-10-21
K223305 — Trevo NXT ProVue Retriever2023-03-29
K222848 — pRESET Thrombectomy Device2023-01-20
K210502 — Trevo NXT ProVue Retriever2021-08-27

More clearances from Concentric Medical, Inc.

view all

K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)2018-02-15
K150616 — Trevo XP ProVue Retriever (4x30mm)2015-06-12
K143077 — Trevo XP ProVue Retriever (6X25mm)2015-04-06
K133177 — MODIFIED HD GUIDE CATHETER2014-02-25
K133464 — MODIFIED TREVO PROVUE RETRIEVER2014-01-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.