FDA.reportPublic FDA data

MicroVention Costa Rica S.R.L.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100790673010079067MicroVention Costa Rica S.R.L.1N2026-01-01Zona Franca Coyol . Alajuela CR .

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1662591679886361P180027Flow Re-Direction Endoluminal Device (FRED®) SystemOUT2019-12-16
1662591579551235P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.QCA2018-05-30
1662591914501814K182829Scepter Mini Occlusion Balloon CatheterDQY2019-07-10
1662591837210951K182602SOFIA EX Intracranial Support CatheterDQY2019-05-15
1662592028980645K173200SOFIA Plus Aspiration CatheterNRY2018-06-11
1662591677112982K172014Wedge MicrocatheterDQY2018-04-05
1662591281161993K162524AZUR CX Detachable 18 Peripheral Coil SystemKRD2017-03-03
1662591576553171K161803Traxcess .007 Mini GuidewireMOF2016-09-30
1662591501059222K161452MicroPlex Coil System (MCS) - HyperSoft 3DHCG2016-08-31
1662591558678554K161367HydroCoil Embolic System (HES)HCG2016-08-31
1662591819693329K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)HCG2016-01-22
1662591583331939K151358AZUR CX Detachable 35 CoilsKRD2015-09-25
1662591308824194K150366SOFIA 6F CatheterDQY2015-03-27
1662591819266780K142449Headway 27 MicrocatheterDQY2015-03-26
1662591074261648K142014SOFIA DISTAL ACCESS CATHETERDQY2014-10-10
1662591576972185K133626AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2013-12-20
1662591630635781K132952MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)HCG2013-12-19
1662591060736843K132317MICROPLEX COIL SYSTEM (MCS), VFCHCG2013-09-20
1662591157909388K132083AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35KRD2013-10-28
1662591450697120K131948MICROPLEX COIL SYSTEM (MCS)HCG2013-10-04
1662591581609937K131482SOFIA DISTAL ACCESS CATHETERDQY2013-11-22
1662591927077561K130577AZUR PUSHABLE 18 & 35 SYSTEMKRD2013-06-17
1662591585153466K123384AZUR CX DETACHABLE 18KRD2012-11-28
1662591205378827K122543AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35KRD2012-11-28
1662591895713560K122316AZUR DETACHABLE 35KRD2012-08-29
1662591790581781K121785SCEPTER C OCCLUSION BALLOON CATHETERMJN2012-08-10
1662591037995311K120917HEADWAY DUO MICROCATHETERDQO2012-08-02
1662591479888533K120908HYDROCOIL EMBOLIC SYSTEM (HES)HCG2012-04-25
1662591685517960K120630AZUR DETACHABLE 18KRD2012-03-28
1662592037636600K113698SCEPTER XC OCCLUSION BALLOON CATHETERMJN2012-01-13
1662591461209748K113457HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-12-16
1662592038930360K112226HYDROCOIL EMBOLIC SYSTEM (HES)HCG2011-09-29
1662591198889450K111451MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XXHCG2011-09-20
1662591753130371K111307AZUR DETACHABLE 35 PLATINUM COIL SYSTEMKRD2011-06-15
1662591396166222K110813HEADWAY 27 MICROCATHETERDQY2011-08-05
1662591718496061K110741SCEPTER C OCCLUSION BALLOON CATHETERMJN2011-09-29
1662591084517854K103758MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10HCG2011-04-28
1662591380098148K102365MICROPLEX COIL SYSTEM- COSMOSKRD2010-11-18
1662591520612489K101542HEADWAY 17 ADVANCED MICROCATHETERDQY2010-08-06
1662591166110467K100454HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-VHCG2010-04-22
1662592048556515K093919MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VHCG2010-01-21
1662591562241315K093358MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-VHCG2010-01-15
1662591686107979K093160HEADWAY 21 MICROCATHETER, MODEL: MC212150SDQY2009-11-05
1662591273985022K093002AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610KRD2009-10-28
1662591725847267K091882AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEMKRD2009-07-08
1662591409213978K091641HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)HCG2009-06-30
1662591923102362K090891MICROPLEX COIL SYSTEM-COSMOSHCG2009-06-22
1662591109070407K090357HYDROFRAME (HES)HCG2009-04-10
1662591467885772K090168AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415HCG2009-03-12
1662591124288398K083343HEADWAY 17 MICROCATHETERDQY2008-12-04
1662591725688925K082461BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622BHCG2008-10-02
1662591208944664K080666HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMSHCG2008-07-11
1662591787637619K071939HYDROCOIL EMBOLIC SYSTEMS (HES)KRD2008-01-11
1662591462842024K070656HYDROCOIL EMBOLIC SYSTEM (HES)HCG2007-06-15
1662591225436450K050954MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES)HCG2005-06-28
1662591803622254K041551MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)HCG2004-07-07
1662591062637393K032590MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)HCG2003-10-22
1662591373875646K022735MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KITHCG2002-09-06
1662591792561709K012145MICROPLEX COIL SYSTEMHCG2001-10-29
1662591172957577H130005
1662591166827327
1662591776461696
1662591037995311
1662591060736843
1662591074261648
1662591084517854
1662591109070407
1662591124288398
1662591157909388
1662591166110467
1662591186524002
1662591198889450
1662591208944664
1662591225436450
1662591273985022
1662591281161993
1662591308824194
1662591319962986
1662591380098148
1662591396166222
1662591407683757
1662591409213978
1662591450697120
1662591461209748
1662591462842024
1662591467885772
1662591479888533
1662591501059222
1662591520612489
1662591558678554
1662591562241315
1662591576972185
1662591579551235
1662591581609937
1662591583331939
1662591585153466
1662591630635781
1662591659276399
1662591679886361
1662591685517960
1662591686107979
1662591707576685
1662591725688925
1662591725847267
1662591753130371
1662591787637619
1662591790581781
1662591797957067
1662591819266780
1662591819693329
1662591837210951
1662591895713560
1662591923102362
1662591927077561
1662591975675047
1662592028980645
1662592038930360
1662592048556515
1662592063181769

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HCG262016-08-31
KRD142017-03-03
DQY112019-07-10
MJN32012-08-10
OUT 12019-12-16
NRY12018-06-11
QCA12018-05-30
MOF12016-09-30
DQO12012-08-02