Company ยท US
MicroVention, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2025. Name variants (Inc, Corp, punctuation) are merged.
86510(k) clearances (0 in 12 months)
38recalls (2 in 12 months)
33recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HCG | Device, Neurovascular Embolization | 48 |
| KRD | Device, Vascular, For Promoting Embolization | 26 |
| DQY | Catheter, Percutaneous | 21 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 7 |
| DQX | Wire, Guide, Catheter | 3 |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 |
| NRY | Catheter, Thrombus Retriever | 3 |
| NOY | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | 2 |
| OUT | Intracranial Aneurysm Flow Diverter | 2 |
| QCA | Intracranial Coil-Assist Stent | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| FMF | Syringe, Piston | 1 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 1 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 1 |
| OPR | Intrasaccular Flow Disruption Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2025 | K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) Microvention | JCX |
| May 16, 2024 | K232542 | Wedge XL Delivery Catheter MicroVention, Inc. | QJP |
| Sep 14, 2023 | K230775 | SOFIA EX Intracranial Support Catheter MicroVention, Inc. | QJP |
| Apr 27, 2023 | K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) MicroVention, Inc. | NTE |
| Jan 10, 2023 | K222115 | ISAAC Neurovascular Navigation Catheter MicroVention, Inc. | DQY |
| Dec 21, 2022 | K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) MicroVention, Inc. | KRD |
| Sep 12, 2022 | K214024 | SOFIA 88 Catheter MicroVention, Inc. | DQY |
| Mar 31, 2022 | K211120 | ERIC Retrieval Device MicroVention, Inc. | NRY |
| Jul 21, 2020 | K193607 | BOBBY Balloon Guide Catheter MicroVention, Inc. | DQY |
| Jul 2, 2020 | K201487 | Traxcess 7 Mini Guidewire MicroVention, Inc. | MOF |
| Apr 16, 2020 | K200547 | Traxcess 14 SELECT Guidewire MicroVention, Inc. | MOF |
| Mar 20, 2020 | K191680 | AZUR Vascular Plug MicroVention, Inc. | KRD |
| Jan 22, 2020 | K192684 | HydroPearl Microspheres MicroVention, Inc. | NOY |
| Dec 24, 2019 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) MicroVention, Inc. | DQY |
| Jul 10, 2019 | K182829 | Scepter Mini Occlusion Balloon Catheter MicroVention, Inc. | DQY |
| May 15, 2019 | K182602 | SOFIA EX Intracranial Support Catheter MicroVention, Inc. | DQY |
| Jun 11, 2018 | K173200 | SOFIA Plus Aspiration Catheter MicroVention, Inc. | NRY |
| Apr 5, 2018 | K172014 | Wedge Microcatheter MicroVention, Inc. | DQY |
| Mar 29, 2017 | K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller MicroVention, Inc. | HCG |
| Mar 3, 2017 | K162524 | AZUR CX Detachable 18 Peripheral Coil System MicroVention, Inc. | KRD |
| Dec 9, 2016 | K163154 | Traxcess 7 Mini XSoft Guidewire MicroVention, Inc. | MOF |
| Sep 30, 2016 | K161803 | Traxcess .007 Mini Guidewire MicroVention, Inc. | MOF |
| Aug 31, 2016 | K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D MicroVention, Inc. | HCG |
| Aug 31, 2016 | K161367 | HydroCoil Embolic System (HES) MicroVention, Inc. | HCG |
| Jan 22, 2016 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MicroVention, Inc. | HCG |
| Dec 29, 2015 | K153053 | Traxcess Pro 14 Guidewire MicroVention, Inc. | MOF |
| Dec 21, 2015 | K150870 | HydroPearl Microspheres, HydroPearl Microspheres MicroVention, Inc. | KRD |
| Sep 25, 2015 | K151358 | AZUR CX Detachable 35 Coils MicroVention, Inc. | KRD |
| Sep 17, 2015 | K150958 | LifePearl Microshperes MicroVention, Inc. | KRD |
| Mar 27, 2015 | K150366 | SOFIA 6F Catheter MicroVention, Inc. | DQY |
| Mar 26, 2015 | K142449 | Headway 27 Microcatheter MicroVention, Inc. | DQY |
| Oct 10, 2014 | K142014 | SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. | DQY |
| Jul 31, 2014 | K133725 | TRAXCESS 14 GUIDEWIRE MicroVention, Inc. | MOF |
| Dec 20, 2013 | K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MicroVention, Inc. | KRD |
| Dec 19, 2013 | K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Nov 22, 2013 | K131482 | SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. | DQY |
| Oct 28, 2013 | K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 MicroVention, Inc. | KRD |
| Oct 4, 2013 | K131948 | MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc. | HCG |
| Sep 20, 2013 | K132317 | MICROPLEX COIL SYSTEM (MCS), VFC MicroVention, Inc. | HCG |
| Jun 17, 2013 | K130577 | AZUR PUSHABLE 18 & 35 SYSTEM MicroVention, Inc. | KRD |
| Nov 28, 2012 | K123384 | AZUR CX DETACHABLE 18 MicroVention, Inc. | KRD |
| Nov 28, 2012 | K122543 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MicroVention, Inc. | KRD |
| Aug 29, 2012 | K122316 | AZUR DETACHABLE 35 MicroVention, Inc. | KRD |
| Aug 10, 2012 | K121785 | SCEPTER C OCCLUSION BALLOON CATHETER MicroVention, Inc. | MJN |
| Aug 2, 2012 | K120917 | HEADWAY DUO MICROCATHETER MicroVention, Inc. | DQO |
| Apr 25, 2012 | K120908 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Mar 28, 2012 | K120630 | AZUR DETACHABLE 18 MicroVention, Inc. | KRD |
| Jan 13, 2012 | K113698 | SCEPTER XC OCCLUSION BALLOON CATHETER MicroVention, Inc. | MJN |
| Dec 16, 2011 | K113457 | HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
| Dec 1, 2011 | K112181 | HYDROCOIL(R) EMBOLIC SYSTEM (HES) MicroVention, Inc. | HCG |
Newest 50 of 86.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | MICROVENTION INC. BOBBY Balloon Guide Catheter
REF:
BOB-895-CN
BOB-895-EMEA
BOB-895-EMEA-AL
BOB-895-US
MV-BGA01095
For use in facilitating the insertion and guidance of an intravascular catheter into a selected blood Open, Classified |
DQY | K193607 |
| May 14, 2026 | MICROVENTION INC. LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm Open, Classified |
QCA | None listed |
| Oct 10, 2025 | MICROVENTION INC. Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827;
FRED X 27, REF: XFRED401 Open, Classified |
OUT | None listed |
| Jul 28, 2025 | MICROVENTION INC. LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 Open, Classified |
KRD | K150958 |
| Feb 7, 2025 | MICROVENTION INC. MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297.
The intended purpose of the LVIS Device is to serve as a stent-assisted coilin Open, Classified |
QCA | None listed |
| Jan 17, 2025 | MICROVENTION INC. Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 Open, Classified |
DQY | K101542 |
| Sep 17, 2024 | MICROVENTION INC. ERIC Retrieval Device REF:
ER173020
ER174030
ER176044
The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive vascul Open, Classified |
NRY | K211120 |
| Jan 31, 2024 | MICROVENTION INC. TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Open, Classified |
NOY | K150870 K192684 |
| Oct 27, 2023 | MICROVENTION INC. AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Open, Classified |
KRD | K151358 |
| Jul 27, 2023 | MICROVENTION INC. FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012- Open, Classified |
OUT | None listed |
| Nov 2, 2022 | MICROVENTION INC. WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. Open, Classified |
OPR | None listed |
| Oct 20, 2021 | MICROVENTION INC. Aspiration Syringe Kit, REF: MVSK60 Terminated |
FMF | K994253 |
| Apr 21, 2021 | MICROVENTION INC. VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated |
DQY | K192135 |
| Apr 21, 2021 | MICROVENTION INC. VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated |
DQY | K192135 |
| Apr 21, 2021 | MICROVENTION INC. VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. Terminated |
DQY | K192135 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, M Terminated |
KRD | K151358 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Terminated |
KRD | K151358 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030 Terminated |
KRD | K151358 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-7 Terminated |
KRD | K120630 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Terminated |
KRD | K120630 |
| Nov 24, 2019 | Microvention, Inc. Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, Terminated |
KRD | K120630 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS Terminated |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC03 Terminated |
HCG | K050954 K131948 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, Terminated |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 10061 Terminated |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, Terminated |
HCG | K050954 K090357 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V Terminated |
HCG | K050954 K090357 +4 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V.
Product Us Terminated |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100 Terminated |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451 Terminated |
HCG | K050954 K090891 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 10051 Terminated |
HCG | K050954 K090891 +4 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S Terminated |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V.
Product Usage: The MCS is also int Terminated |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HC Terminated |
HCG | K050954 K091641 +3 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620 Terminated |
HCG | K050954 K131948 +2 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 10 Terminated |
HCG | K050954 K091641 +4 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 1001 Terminated |
HCG | K050954 K091641 +3 |
| Aug 7, 2017 | Microvention, Inc. MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. Terminated |
MOF | K161803 |