Flow Re-Direction Endoluminal (FRED) and FRED X System
MicroVention, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013556777 | 3013556777 | MicroVention, Inc. | 1 | N | 2026-01-01 | 35 Enterprise Aliso Viejo CA US 92656 |
| 2032493 | 3003523199 | MICROVENTION, INC. | 1 | N | 2020-04-25 | 1311 Valencia Avenue Tustin CA US 92780 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00842429108444 | Sofia - Sofia 6F-115cm STR | +1(888) 775-0182 | customerservice@microvention.com |
| 00842429108451 | Sofia - Sofia 6F-125cm STR | +1(888) 775-0182 | customerservice@microvention.com |
| 00842429108468 | Sofia - Sofia 6F-131cm STR | +1(888) 775-0182 | customerservice@microvention.com |
| 00842429108574 | BOBBY/SOFIA Kit - SF6131-B895-US | +1(714) 247-8000 | customerservice@microvention.com |
| 00842429113608 | ISAAC - ISAAC Catheter - SIM2 | +1(714) 247-8000 | customerservice@microvention.com |
| 00842429113615 | ISAAC - ISAAC Catheter - SIM3 | +1(714) 247-8000 | customerservice@microvention.com |
| 00842429113622 | ISAAC - ISAAC Catheter -TIP45 | +1(714) 247-8000 | customerservice@microvention.com |
| 00842429118092 | Access - Sofia EX 5F - 115cm STR | +1(714) 247-8000 | customerservice@microvention.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208685 | 1707576685 | P210030 | Roadsaver/CASPER Carotid Stent Device | NIM | 2024-11-20 |
| 121748 | 1679886361 | P180027 | Flow Re-Direction Endoluminal Device (FREDĀ®) System | OUT | 2019-12-16 |
| 208685 | 1679886361 | P180027 | Flow Re-Direction Endoluminal Device (FREDĀ®) System | OUT | 2019-12-16 |
| 208685 | 1797957067 | P170032 | Woven EndoBridge (WEB) Aneurysm Embolization System | OPR | 2018-12-31 |
| 121748 | 1797957067 | P170032 | Woven EndoBridge (WEB) Aneurysm Embolization System | OPR | 2018-12-31 |
| 121748 | 1579551235 | P170013 | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. | QCA | 2018-05-30 |
| 208685 | 1579551235 | P170013 | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. | QCA | 2018-05-30 |
| 208685 | 1713757441 | K994253 | VACLOK SYRINGE | FMF | 2000-01-05 |
| 208685 | 1659276399 | K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | JCX | 2025-06-13 |
| 208685 | 1468267447 | K232542 | Wedge XL Delivery Catheter | QJP | 2024-05-16 |
| 208685 | 2063181769 | K230775 | SOFIA EX Intracranial Support Catheter | QJP | 2023-09-14 |
| 208685 | 1398531936 | K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | KRD | 2022-12-21 |
| 208685 | 1101283187 | K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | NTE | 2023-04-27 |
| 208685 | 1407683757 | K222115 | ISAAC Neurovascular Navigation Catheter | DQY | 2023-01-10 |
| 208685 | 1937303084 | K214024 | SOFIA 88 Catheter | DQY | 2022-09-12 |
| 208685 | 1476960972 | K211120 | ERIC Retrieval Device | NRY | 2022-03-31 |
| 208685 | 1301965965 | K201487 | Traxcess 7 Mini Guidewire | MOF | 2020-07-02 |
| 208685 | 1487057414 | K200547 | Traxcess 14 SELECT Guidewire | MOF | 2020-04-16 |
| 208685 | 1975675047 | K193607 | BOBBY Balloon Guide Catheter | DQY | 2020-07-21 |
| 208685 | 1875580502 | K192684 | HydroPearl Microspheres | NOY | 2020-01-22 |
| 121748 | 1875580502 | K192684 | HydroPearl Microspheres | NOY | 2020-01-22 |
| 208685 | 1757501944 | K192625 | PG Pro Microcatheter | DQY | 2019-11-21 |
| 121748 | 1757501944 | K192625 | PG Pro Microcatheter | DQY | 2019-11-21 |
| 208685 | 1186524002 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | DQY | 2019-12-24 |
| 121748 | 1186524002 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | DQY | 2019-12-24 |
| 208685 | 1564528676 | K191680 | AZUR Vascular Plug | KRD | 2020-03-20 |
| 208685 | 1914501814 | K182829 | Scepter Mini Occlusion Balloon Catheter | DQY | 2019-07-10 |
| 121748 | 1914501814 | K182829 | Scepter Mini Occlusion Balloon Catheter | DQY | 2019-07-10 |
| 208685 | 1837210951 | K182602 | SOFIA EX Intracranial Support Catheter | DQY | 2019-05-15 |
| 121748 | 1837210951 | K182602 | SOFIA EX Intracranial Support Catheter | DQY | 2019-05-15 |
| 121748 | 2028980645 | K173200 | SOFIA Plus Aspiration Catheter | NRY | 2018-06-11 |
| 208685 | 2028980645 | K173200 | SOFIA Plus Aspiration Catheter | NRY | 2018-06-11 |
| 121748 | 1677112982 | K172014 | Wedge Microcatheter | DQY | 2018-04-05 |
| 208685 | 1677112982 | K172014 | Wedge Microcatheter | DQY | 2018-04-05 |
| 121748 | 1243627328 | K163154 | Traxcess 7 Mini XSoft Guidewire | MOF | 2016-12-09 |
| 208685 | 1243627328 | K163154 | Traxcess 7 Mini XSoft Guidewire | MOF | 2016-12-09 |
| 121748 | 1319962986 | K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System | HCG | 2017-03-29 |
| 208685 | 1319962986 | K162999 | V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System | HCG | 2017-03-29 |
| 121748 | 1281161993 | K162524 | AZUR CX Detachable 18 Peripheral Coil System | KRD | 2017-03-03 |
| 208685 | 1281161993 | K162524 | AZUR CX Detachable 18 Peripheral Coil System | KRD | 2017-03-03 |
| 121748 | 1576553171 | K161803 | Traxcess .007 Mini Guidewire | MOF | 2016-09-30 |
| 208685 | 1576553171 | K161803 | Traxcess .007 Mini Guidewire | MOF | 2016-09-30 |
| 121748 | 1501059222 | K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | HCG | 2016-08-31 |
| 208685 | 1501059222 | K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | HCG | 2016-08-31 |
| 121748 | 1558678554 | K161367 | HydroCoil Embolic System (HES) | HCG | 2016-08-31 |
| 208685 | 1558678554 | K161367 | HydroCoil Embolic System (HES) | HCG | 2016-08-31 |
| 208685 | 1819693329 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | HCG | 2016-01-22 |
| 121748 | 1819693329 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | HCG | 2016-01-22 |
| 121748 | 1453359459 | K153053 | Traxcess Pro 14 Guidewire | MOF | 2015-12-29 |
| 208685 | 1453359459 | K153053 | Traxcess Pro 14 Guidewire | MOF | 2015-12-29 |
| 121748 | 1583331939 | K151358 | AZUR CX Detachable 35 Coils | KRD | 2015-09-25 |
| 208685 | 1583331939 | K151358 | AZUR CX Detachable 35 Coils | KRD | 2015-09-25 |
| 121748 | 1798907066 | K150958 | LifePearl Microshperes | KRD | 2015-09-17 |
| 208685 | 1798907066 | K150958 | LifePearl Microshperes | KRD | 2015-09-17 |
| 121748 | 1771897063 | K150870 | HydroPearl Microspheres, HydroPearl Microspheres | KRD | 2015-12-21 |
| 208685 | 1771897063 | K150870 | HydroPearl Microspheres, HydroPearl Microspheres | KRD | 2015-12-21 |
| 121748 | 1308824194 | K150366 | SOFIA 6F Catheter | DQY | 2015-03-27 |
| 208685 | 1308824194 | K150366 | SOFIA 6F Catheter | DQY | 2015-03-27 |
| 121748 | 1819266780 | K142449 | Headway 27 Microcatheter | DQY | 2015-03-26 |
| 208685 | 1819266780 | K142449 | Headway 27 Microcatheter | DQY | 2015-03-26 |
| 121748 | 1074261648 | K142014 | SOFIA DISTAL ACCESS CATHETER | DQY | 2014-10-10 |
| 208685 | 1074261648 | K142014 | SOFIA DISTAL ACCESS CATHETER | DQY | 2014-10-10 |
| 121748 | 1581607149 | K133725 | TRAXCESS 14 GUIDEWIRE | MOF | 2014-07-31 |
| 208685 | 1581607149 | K133725 | TRAXCESS 14 GUIDEWIRE | MOF | 2014-07-31 |
| 121748 | 1576972185 | K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | KRD | 2013-12-20 |
| 208685 | 1576972185 | K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | KRD | 2013-12-20 |
| 121748 | 1630635781 | K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | 2013-12-19 |
| 208685 | 1630635781 | K132952 | MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | 2013-12-19 |
| 121748 | 1060736843 | K132317 | MICROPLEX COIL SYSTEM (MCS), VFC | HCG | 2013-09-20 |
| 208685 | 1060736843 | K132317 | MICROPLEX COIL SYSTEM (MCS), VFC | HCG | 2013-09-20 |
| 121748 | 1157909388 | K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 | KRD | 2013-10-28 |
| 208685 | 1157909388 | K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 | KRD | 2013-10-28 |
| 121748 | 1450697120 | K131948 | MICROPLEX COIL SYSTEM (MCS) | HCG | 2013-10-04 |
| 208685 | 1450697120 | K131948 | MICROPLEX COIL SYSTEM (MCS) | HCG | 2013-10-04 |
| 121748 | 1581609937 | K131482 | SOFIA DISTAL ACCESS CATHETER | DQY | 2013-11-22 |
| 208685 | 1581609937 | K131482 | SOFIA DISTAL ACCESS CATHETER | DQY | 2013-11-22 |
| 121748 | 1927077561 | K130577 | AZUR PUSHABLE 18 & 35 SYSTEM | KRD | 2013-06-17 |
| 208685 | 1927077561 | K130577 | AZUR PUSHABLE 18 & 35 SYSTEM | KRD | 2013-06-17 |
| 121748 | 1585153466 | K123384 | AZUR CX DETACHABLE 18 | KRD | 2012-11-28 |
| 208685 | 1585153466 | K123384 | AZUR CX DETACHABLE 18 | KRD | 2012-11-28 |
| 121748 | 1205378827 | K122543 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | KRD | 2012-11-28 |
| 208685 | 1205378827 | K122543 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | KRD | 2012-11-28 |
| 121748 | 1895713560 | K122316 | AZUR DETACHABLE 35 | KRD | 2012-08-29 |
| 208685 | 1895713560 | K122316 | AZUR DETACHABLE 35 | KRD | 2012-08-29 |
| 121748 | 1790581781 | K121785 | SCEPTER C OCCLUSION BALLOON CATHETER | MJN | 2012-08-10 |
| 208685 | 1790581781 | K121785 | SCEPTER C OCCLUSION BALLOON CATHETER | MJN | 2012-08-10 |
| 121748 | 1037995311 | K120917 | HEADWAY DUO MICROCATHETER | DQO | 2012-08-02 |
| 208685 | 1037995311 | K120917 | HEADWAY DUO MICROCATHETER | DQO | 2012-08-02 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HCG | 79 | 2017-03-29 |
| KRD | 47 | 2022-12-21 |
| DQY | 44 | 2023-01-10 |
| MOF | 12 | 2020-07-02 |
| DQX | 8 | 2010-02-24 |
| MJN | 7 | 2012-08-10 |
| NRY | 4 | 2022-03-31 |
| NOY | 3 | 2020-01-22 |
| OUT | 3 | 2019-12-16 |
| OPR | 3 | 2018-12-31 |
| DQO | 3 | 2012-08-02 |
| QJP | 2 | 2024-05-16 |
| QCA | 2 | 2018-05-30 |
| FMF | 2 | 2000-01-05 |
| JCX | 1 | 2025-06-13 |
| NTE | 1 | 2023-04-27 |
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MicroVention, Inc.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MicroVention, Inc.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
MICROVENTION, INC.
2025-04-30
2025-04-30
2025-04-30
2025-04-30
2024-10-18
2024-10-18
2024-10-18
2024-10-18
2023-06-15
2019-09-25
2019-09-25
2016-09-24
2018-08-07
2018-08-07
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24
2016-09-24