FDA.report

MicroVention Costa Rica S.R.L.

Matched from indexed company URL: MICROVENTION INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30100790673010079067MicroVention Costa Rica S.R.L.1N2026-01-01Zona Franca Coyol . Alajuela CR .
30135567773013556777MicroVention, Inc.1N2026-01-0135 Enterprise Aliso Viejo CA US 92656
20324933003523199MICROVENTION, INC.1N2020-04-251311 Valencia Avenue Tustin CA US 92780

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00811425020852Roadsaver Carotid Atery Stent - RDS-0520-143RX-MVI+1(714) 247-8000customerservice@microvention.com
00816777020116V-Grip Detachment Controller - VG900+1(714) 247-8000customerservice@microvention.com
00840273201991AZUR Detachment Controller - 45-4001-02+1(714) 247-8000customerservice@microvention.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2086851707576685P210030Roadsaver/CASPER Carotid Stent DeviceNIM2024-11-20
1217481679886361P180027Flow Re-Direction Endoluminal Device (FRED®) SystemOUT2019-12-16
1662591679886361P180027Flow Re-Direction Endoluminal Device (FRED®) SystemOUT2019-12-16
2086851679886361P180027Flow Re-Direction Endoluminal Device (FRED®) SystemOUT2019-12-16
1217481797957067P170032Woven EndoBridge (WEB) Aneurysm Embolization SystemOPR2018-12-31
2086851797957067P170032Woven EndoBridge (WEB) Aneurysm Embolization SystemOPR2018-12-31
1217481579551235P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.QCA2018-05-30
1662591579551235P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.QCA2018-05-30
2086851579551235P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.QCA2018-05-30
2086851713757441K994253VACLOK SYRINGEFMF2000-01-05
2086851659276399K243638MV Flow Aspiration Pump (MVFLOWPMP01)JCX2025-06-13
2086851468267447K232542Wedge XL Delivery CatheterQJP2024-05-16
2086852063181769K230775SOFIA EX Intracranial Support CatheterQJP2023-09-14
2086851398531936K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD2022-12-21
2086851101283187K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE2023-04-27
2086851407683757K222115ISAAC Neurovascular Navigation CatheterDQY2023-01-10
2086851937303084K214024SOFIA 88 CatheterDQY2022-09-12
2086851476960972K211120ERIC Retrieval DeviceNRY2022-03-31
2086851301965965K201487Traxcess 7 Mini GuidewireMOF2020-07-02
2086851487057414K200547Traxcess 14 SELECT GuidewireMOF2020-04-16
2086851975675047K193607BOBBY Balloon Guide CatheterDQY2020-07-21
1217481875580502K192684HydroPearl MicrospheresNOY2020-01-22
2086851875580502K192684HydroPearl MicrospheresNOY2020-01-22
1217481757501944K192625PG Pro MicrocatheterDQY2019-11-21
2086851757501944K192625PG Pro MicrocatheterDQY2019-11-21
1217481186524002K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)DQY2019-12-24
2086851186524002K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)DQY2019-12-24
2086851564528676K191680AZUR Vascular PlugKRD2020-03-20
1217481914501814K182829Scepter Mini Occlusion Balloon CatheterDQY2019-07-10
1662591914501814K182829Scepter Mini Occlusion Balloon CatheterDQY2019-07-10
2086851914501814K182829Scepter Mini Occlusion Balloon CatheterDQY2019-07-10
1217481837210951K182602SOFIA EX Intracranial Support CatheterDQY2019-05-15
1662591837210951K182602SOFIA EX Intracranial Support CatheterDQY2019-05-15
2086851837210951K182602SOFIA EX Intracranial Support CatheterDQY2019-05-15
1217482028980645K173200SOFIA Plus Aspiration CatheterNRY2018-06-11
1662592028980645K173200SOFIA Plus Aspiration CatheterNRY2018-06-11
2086852028980645K173200SOFIA Plus Aspiration CatheterNRY2018-06-11
1217481677112982K172014Wedge MicrocatheterDQY2018-04-05
1662591677112982K172014Wedge MicrocatheterDQY2018-04-05
2086851677112982K172014Wedge MicrocatheterDQY2018-04-05
1217481243627328K163154Traxcess 7 Mini XSoft GuidewireMOF2016-12-09
2086851243627328K163154Traxcess 7 Mini XSoft GuidewireMOF2016-12-09
1217481319962986K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil SystemHCG2017-03-29
2086851319962986K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil SystemHCG2017-03-29
1217481281161993K162524AZUR CX Detachable 18 Peripheral Coil SystemKRD2017-03-03
1662591281161993K162524AZUR CX Detachable 18 Peripheral Coil SystemKRD2017-03-03
2086851281161993K162524AZUR CX Detachable 18 Peripheral Coil SystemKRD2017-03-03
1217481576553171K161803Traxcess .007 Mini GuidewireMOF2016-09-30
1662591576553171K161803Traxcess .007 Mini GuidewireMOF2016-09-30
2086851576553171K161803Traxcess .007 Mini GuidewireMOF2016-09-30
1217481501059222K161452MicroPlex Coil System (MCS) - HyperSoft 3DHCG2016-08-31
1662591501059222K161452MicroPlex Coil System (MCS) - HyperSoft 3DHCG2016-08-31
2086851501059222K161452MicroPlex Coil System (MCS) - HyperSoft 3DHCG2016-08-31
1217481558678554K161367HydroCoil Embolic System (HES)HCG2016-08-31
1662591558678554K161367HydroCoil Embolic System (HES)HCG2016-08-31
2086851558678554K161367HydroCoil Embolic System (HES)HCG2016-08-31
1217481819693329K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG2016-01-22
1662591819693329K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG2016-01-22
2086851819693329K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG2016-01-22
1217481453359459K153053Traxcess Pro 14 GuidewireMOF2015-12-29
2086851453359459K153053Traxcess Pro 14 GuidewireMOF2015-12-29
1217481583331939K151358AZUR CX Detachable 35 CoilsKRD2015-09-25
1662591583331939K151358AZUR CX Detachable 35 CoilsKRD2015-09-25
2086851583331939K151358AZUR CX Detachable 35 CoilsKRD2015-09-25
1217481798907066K150958LifePearl MicroshperesKRD2015-09-17
2086851798907066K150958LifePearl MicroshperesKRD2015-09-17
1217481771897063K150870HydroPearl Microspheres, HydroPearl MicrospheresKRD2015-12-21
2086851771897063K150870HydroPearl Microspheres, HydroPearl MicrospheresKRD2015-12-21
1217481308824194K150366SOFIA 6F CatheterDQY2015-03-27
1662591308824194K150366SOFIA 6F CatheterDQY2015-03-27
2086851308824194K150366SOFIA 6F CatheterDQY2015-03-27
1217481819266780K142449Headway 27 MicrocatheterDQY2015-03-26
1662591819266780K142449Headway 27 MicrocatheterDQY2015-03-26
2086851819266780K142449Headway 27 MicrocatheterDQY2015-03-26
1217481074261648K142014SOFIA DISTAL ACCESS CATHETERDQY2014-10-10
1662591074261648K142014SOFIA DISTAL ACCESS CATHETERDQY2014-10-10
2086851074261648K142014SOFIA DISTAL ACCESS CATHETERDQY2014-10-10
1217481581607149K133725TRAXCESS 14 GUIDEWIREMOF2014-07-31
2086851581607149K133725TRAXCESS 14 GUIDEWIREMOF2014-07-31
1217481576972185K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2013-12-20
1662591576972185K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2013-12-20
2086851576972185K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2013-12-20
1217481630635781K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)HCG2013-12-19
1662591630635781K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)HCG2013-12-19
2086851630635781K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)HCG2013-12-19
1217481060736843K132317MICROPLEX COIL SYSTEM (MCS), VFCHCG2013-09-20
1662591060736843K132317MICROPLEX COIL SYSTEM (MCS), VFCHCG2013-09-20
2086851060736843K132317MICROPLEX COIL SYSTEM (MCS), VFCHCG2013-09-20
1217481157909388K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35KRD2013-10-28
1662591157909388K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35KRD2013-10-28
2086851157909388K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35KRD2013-10-28
1217481450697120K131948MICROPLEX COIL SYSTEM (MCS)HCG2013-10-04
1662591450697120K131948MICROPLEX COIL SYSTEM (MCS)HCG2013-10-04
2086851450697120K131948MICROPLEX COIL SYSTEM (MCS)HCG2013-10-04

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HCG1052017-03-29
KRD612022-12-21
DQY552023-01-10
MOF132020-07-02
MJN102012-08-10
DQX82010-02-24
NRY52022-03-31
OUT 42019-12-16
DQO42012-08-02
NOY32020-01-22
OPR32018-12-31
QCA32018-05-30
QJP22024-05-16
FMF22000-01-05
JCX12025-06-13
NTE12023-04-27

PMA

Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

2022-12-09

MicroVention, Inc.35 Enterprisealiso Viejo, CA 92656 PMA NumberP170013 Supplement NumberS010 Date Received11/09/2022 Decision Date12/09/2022 Product Code QCA  Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Pos...

Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

2022-06-28

MicroVention, Inc.35 Enterprisealiso Viejo, CA 92656 PMA NumberP170013 Supplement NumberS009 Date Received06/10/2022 Decision Date06/28/2022 Product Code QCA  Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Pos...

Flow Re-Direction Endoluminal (FRED) and FRED X System

2022-03-25

MicroVention, Inc.35 Enterpricsealiso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS008 Date Received03/07/2022 Decision Date03/25/2022 Product Code OUT  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manu...

Flow Re-Direction Endoluminal (FRED®) System, FREDX System

2022-03-01

MicroVention, Inc.35 Enterpricsealiso Viejo, CA 92656 PMA NumberP180027 Supplement NumberS007 Date Received01/31/2022 Decision Date03/01/2022 Product Code OUT  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manu...

PMN

75 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next