Medical Device Manufacturer · US , Aliso Viejo , CA

MicroVention, Inc.

85 submissions · 85 cleared · Since 2001
85
Total
85
Cleared
0
Denied

MicroVention, Inc. — FDA 510(k) Submissions

MicroVention, Inc. has submitted 85 FDA 510(k) premarket notifications since 2001, of which 85 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Device, Neurovascular Embolization, Device, Vascular, For Promoting Embolization, Catheter, Percutaneous, Guide, Wire, Catheter, Neurovasculature, Wire, Guide, Catheter . Use the specialty filter in the sidebar to narrow results.

85 devices
1–25 of 85
Wedge XL Delivery Catheter
K232542 · QJP Catheter, Percutaneous,... · Neurology
May 2024 268d
SOFIA EX Intracranial Support Catheter
K230775 · QJP Catheter, Percutaneous,... · Neurology
Sep 2023 177d
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
K222694 · NTE Temporary Carotid... · Cardiovascular
Apr 2023 233d
ISAAC Neurovascular Navigation Catheter
K222115 · DQY Catheter, Percutaneous · Neurology
Jan 2023 176d
AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
K223050 · KRD Device, Vascular, For... · Cardiovascular
Dec 2022 83d
SOFIA 88 Catheter
K214024 · DQY Catheter, Percutaneous · Neurology
Sep 2022 264d
ERIC Retrieval Device
K211120 · NRY Catheter, Thrombus Retriever · Neurology
Mar 2022 350d
BOBBY Balloon Guide Catheter
K193607 · DQY Catheter, Percutaneous · Neurology
Jul 2020 208d
Traxcess 7 Mini Guidewire
K201487 · MOF Guide, Wire, Catheter,... · Neurology
Jul 2020 28d
Traxcess 14 SELECT Guidewire
K200547 · MOF Guide, Wire, Catheter,... · Neurology
Apr 2020 44d
AZUR Vascular Plug
K191680 · KRD Device, Vascular, For... · Cardiovascular
Mar 2020 270d
HydroPearl Microspheres
K192684 · NOY Agents, Embolic, For... · Gastroenterology & Urology
Jan 2020 118d
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
K192135 · DQY Catheter, Percutaneous · Neurology
Dec 2019 139d
Scepter Mini Occlusion Balloon Catheter
K182829 · DQY Catheter, Percutaneous · Neurology
Jul 2019 278d
SOFIA EX Intracranial Support Catheter
K182602 · DQY Catheter, Percutaneous · Neurology
May 2019 236d
SOFIA Plus Aspiration Catheter
K173200 · NRY Catheter, Thrombus Retriever · Neurology
Jun 2018 252d
Wedge Microcatheter
K172014 · DQY Catheter, Percutaneous · Cardiovascular
Apr 2018 276d
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
K162999 · HCG Device, Neurovascular... · Neurology
Mar 2017 152d
AZUR CX Detachable 18 Peripheral Coil System
K162524 · KRD Device, Vascular, For... · Cardiovascular
Mar 2017 175d
Traxcess 7 Mini XSoft Guidewire
K163154 · MOF Guide, Wire, Catheter,... · Neurology
Dec 2016 29d
Traxcess .007 Mini Guidewire
K161803 · MOF Guide, Wire, Catheter,... · Neurology
Sep 2016 92d
HydroCoil Embolic System (HES)
K161367 · HCG Device, Neurovascular... · Neurology
Aug 2016 106d
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · HCG Device, Neurovascular... · Neurology
Aug 2016 97d
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · HCG Device, Neurovascular... · Neurology
Jan 2016 37d
Traxcess Pro 14 Guidewire
K153053 · MOF Guide, Wire, Catheter,... · Neurology
Dec 2015 70d

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