Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)

Q: What is the product code of K173352?

The FDA product code is POL – Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, a Class II (moderate risk) device regulated under 21 CFR 882.5600.

FDA 510(k) K173352 · Concentric Medical, Inc.

Substantially Equivalent

510(k) numberK173352

Submission

Device name: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
Applicant: Concentric Medical, Inc.
Mountain View, CA, US
Received: October 25, 2017
Decision date: February 15, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Expedited review: Yes

Official FDA 510(k) record

Device classification

Product code: POL – Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5600
Specialty: Neurology

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 510(k)s with product code POL

510(k)	Device	Applicant	Decision
K242676	pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DevicePOL · Special	Phenox Limited	02/28/2025SE
K231539	pRESET LITE Thrombectomy DevicePOL · Traditional	Phenox Limited	10/21/2023SE
K223305	Trevo NXT ProVue RetrieverPOL · Traditional	Stryker Neurovascular	03/29/2023SE
K222848	pRESET Thrombectomy DevicePOL · Traditional	Phenox Limited	01/20/2023SE
K210502	Trevo NXT ProVue RetrieverPOL · Traditional	Stryker Neurovascular	08/27/2021SE
K203358	Solitaire X Revascularization DevicePOL · Traditional	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	03/01/2021SE
K203219	Trevo XP ProVue Retriever and Trevo NXT ProVue RetrieverPOL · Traditional	Stryker Neurovascular	12/29/2020SE
K193576	Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	11/20/2020SE
K200117	Trevo NXT ProVue RetrieverPOL · Special	Stryker	02/07/2020SE
K192207	Trevo NXT ProVue RetrieverPOL · Traditional	Stryker	11/22/2019SE

More from Stryker

510(k)	Device	Decision
K153729	8F FlowGate2 Balloon Guide CatheterDQY · Special	01/27/2016SE
K150616	Trevo XP ProVue Retriever (4x30mm)NRY · Traditional	06/12/2015SE
K143077	Trevo XP ProVue Retriever (6X25mm)NRY · Traditional	04/06/2015SE
K133177	Modified HD Guide CatheterDQY · Traditional	02/25/2014SE
K133464	Modified Trevo Provue RetrieverNRY · Special	01/17/2014SE
K132641	Modified Trevo Provue RetrieverNRY · Traditional	01/13/2014SE
K131437	Modified Concentric MicrocatheterDQO · Traditional	10/11/2013SE
K131492	Modified Flowgate Balloon Guide CatheterDQY · Traditional	10/03/2013SE
K122581	Modified Balloon Guide Catheter Model 90253, 90254DQY · Traditional	11/21/2012SE
K122478	Modified Trevo RetrieverNRY · Traditional	10/31/2012SE

Questions and answers

When was Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) cleared by the FDA?

Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (K173352) received a 510(k) decision of Substantially Equivalent on February 15, 2018, 113 days after the submission was received.

What is the product code of K173352?

The FDA product code is POL – Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment, a Class II (moderate risk) device regulated under 21 CFR 882.5600.