FDA 510(k) Applications for Medical Device Product Code: POL ()

FDA 510(k) Applications for Medical Device Product Code "POL"

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN150049	CONCENTRIC MEDICAL, INC.	Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm	09/02/2016
K173352	Concentric Medical, Inc.	Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)	02/15/2018
K181060	Medtronic Neurovascular	Solitaire 2 and Solitaire Platinum Revascularization Device	08/24/2018
K203358	Micro Therapeutics, Inc d/b/a ev3 Neurovascular	Solitaire X Revascularization Device	03/01/2021
K162539	MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	Solitaire 2 Revascularization Device	11/10/2016
K181807	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device)	03/06/2019
K183022	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	Solitaire 4 Revascularization Device	01/29/2019
K193576	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)	11/20/2020
K181186	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	Solitare Platinum Revascularization Device	10/25/2018
K222848	phenox Limited	pRESET Thrombectomy Device	01/20/2023
K192207	Stryker	Trevo NXT ProVue Retriever	11/22/2019
K200117	Stryker	Trevo NXT ProVue Retriever	02/07/2020
K190779	Stryker	Trevo XP ProVue Retriever	06/25/2019
K210502	Stryker Neurovascular	Trevo NXT ProVue Retriever	08/27/2021
K223305	Stryker Neurovascular	Trevo NXT ProVue Retriever	03/29/2023
K203219	Stryker Neurovascular	Trevo XP ProVue Retriever and Trevo NXTÖ ProVue Retriever	12/29/2020