Trevo NXT ProVue Retriever

Q: What is the product code of K200117?

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) K200117 · Stryker

Substantially Equivalent

510(k) numberK200117

Submission

Device name: Trevo NXT ProVue Retriever
Applicant: Stryker
Fremont, CA, US
Received: January 21, 2020
Decision date: February 7, 2020
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

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
K192207	Trevo NXT ProVue RetrieverPOL · Traditional	Stryker	11/22/2019SE
K190779	Trevo XP ProVue RetrieverPOL · Traditional	Stryker	06/25/2019SE

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K233919	VariAx 2 Distal Radius SystemHRS · Traditional	03/25/2024SE
K233741	Hoffmann LRF SystemKTT · Special	12/21/2023SE
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Questions and answers

When was Trevo NXT ProVue Retriever cleared by the FDA?

Trevo NXT ProVue Retriever (K200117) received a 510(k) decision of Substantially Equivalent on February 7, 2020, 17 days after the submission was received.

What is the product code of K200117?

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.