Trevo NXT ProVue Retriever

Q: What is the product code of K223305?

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) K223305 · Stryker Neurovascular

Substantially Equivalent

510(k) numberK223305

Submission

Device name: Trevo NXT ProVue Retriever
Applicant: Stryker Neurovascular
Fremont, CA, US
Received: October 27, 2022
Decision date: March 29, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
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
K190779	Trevo XP ProVue RetrieverPOL · Traditional	Stryker	06/25/2019SE

More from Stryker

510(k)	Device	Decision
K261889	Trevo Trak 21 MicrocatheterQJP · Special	07/01/2026SE
K253032	AXS Lift Intracranial Base CatheterQJP · Traditional	02/11/2026SE
K252694	Target Detachable CoilHCG · Traditional	12/11/2025SE
K251832	InZone IST Detachment System; IZDS Connecting CableHCG · Special	10/17/2025SE
K242289	Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…QJP · Special	03/21/2025SE
K243593	AXS Lift Intracranial Base CatheterQJP · Traditional	02/18/2025SE
K241768	Broadway 8 CatheterQJP · Traditional	12/19/2024SE
K241637	Echo Intracranial Base CatheterQJP · Traditional	12/19/2024SE
K222533	Target Tetra Detachable CoilsHCG · Traditional	12/14/2022SE
K211594	Trevo Trak 21 MicrocatheterQJP · Special	11/26/2021SE

Questions and answers

When was Trevo NXT ProVue Retriever cleared by the FDA?

Trevo NXT ProVue Retriever (K223305) received a 510(k) decision of Substantially Equivalent on March 29, 2023, 153 days after the submission was received.

What is the product code of K223305?

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.