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MicroVention, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories12
Latest FDA decision2026-07-07
TypeNumberDevice NameCodeDateActions
PMA P210030 Stent, carotidNIM2026-07-07 View
PMA P170032 Intrasaccular Flow Disruption DeviceOPR2026-05-28 View
PMA P180027 Intracranial aneurysm flow diverterOUT2025-11-02 View
PMA P170013 Intracranial coil-assist stentQCA2024-08-21 View
510(k) K232542 Wedge XL Delivery CatheterQJP2024-05-16 View
510(k) K230775 SOFIA EX Intracranial Support CatheterQJP2023-09-14 View
510(k) K222694 EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE2023-04-27 View
510(k) K222115 ISAAC Neurovascular Navigation CatheterDQY2023-01-10 View
510(k) K223050 AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD2022-12-21 View
510(k) K214024 SOFIA 88 CatheterDQY2022-09-12 View
510(k) K211120 ERIC Retrieval DeviceNRY2022-03-31 View
510(k) K193607 BOBBY Balloon Guide CatheterDQY2020-07-21 View
510(k) K201487 Traxcess 7 Mini GuidewireMOF2020-07-02 View
510(k) K200547 Traxcess 14 SELECT GuidewireMOF2020-04-16 View
510(k) K191680 AZUR Vascular PlugKRD2020-03-20 View
510(k) K192684 HydroPearl MicrospheresNOY2020-01-22 View
510(k) K192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)DQY2019-12-24 View
510(k) K182829 Scepter Mini Occlusion Balloon CatheterDQY2019-07-10 View
510(k) K182602 SOFIA EX Intracranial Support CatheterDQY2019-05-15 View
510(k) K173200 SOFIA Plus Aspiration CatheterNRY2018-06-11 View

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