Solitaire X Revascularization Device

Q: What is the product code of K203358?

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) K203358 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

Substantially Equivalent

510(k) numberK203358

Submission

Device name: Solitaire X Revascularization Device
Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US
Received: November 16, 2020
Decision date: March 1, 2021
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
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
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
K241388	Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…QJP · Special	01/02/2025SE
K243418	Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special	12/02/2024SE
K243080	Riptide Aspiration SystemNRY · Special	10/29/2024SE
K211990	Rist 071 Radial Access Guide CatheterDQY · Special	07/27/2021SE
K203432	Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional	07/07/2021SE
K202850	Concerto Versa, Detachable CoilKRD · Traditional	02/09/2021SE
K193576	Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional	11/20/2020SE
K202318	Marathon Flow Directed Micro CatheterKRA · Special	09/14/2020SE
K201690	Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special	07/21/2020SE
K201689	Riptide Aspiration SystemNRY · Special	07/21/2020SE

Questions and answers

When was Solitaire X Revascularization Device cleared by the FDA?

Solitaire X Revascularization Device (K203358) received a 510(k) decision of Substantially Equivalent on March 1, 2021, 105 days after the submission was received.

What is the product code of K203358?

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.