Irina Kulinets

FDA Filings

This page includes the latest FDA filings for Irina Kulinets. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010079067
FEI Number3010079067
NameIrina Kulinets
Owner & OperatorMicroVention Inc.
Contact Address1311 Valencia Avenue
Tustin CA 92780 US
Official Correspondent
  • Irina Kulinets
  • x-714-2478159-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1311 Valencia Avenue
Tustin, CA 92780 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Irina Kulinets [MicroVention Inc.]
Scepter Mini Occlusion Balloon Catheter2020-01-20
Irina Kulinets [MicroVention Inc.]
SOFIA EX2019-06-05
Irina Kulinets [MicroVention Inc.]
SOFIA Plus Aspiration with Tubing Kit2018-06-26
Irina Kulinets [MicroVention Inc.]
Intraluminal Support Device LVIS and LVIS Jr/2018-06-18
Irina Kulinets [MicroVention Inc.]
Wedge2018-04-13
Irina Kulinets [MicroVention Inc.]
MicroPlex Coil System, HydroCoil Embolic System2017-06-09
Irina Kulinets [MicroVention Inc.]
AZUR CX Detachable 18 Peripheral Coil System2017-03-06
Irina Kulinets [MicroVention Inc.]
Carotid Artery Stent (CASPER/Roadsaver)2017-01-04
Irina Kulinets [MicroVention Inc.]
Traxcess 7 Mini Guidewire2016-11-29
Irina Kulinets [MicroVention Inc.]
Traxcess 7 Mini Guidewire2016-11-29
Irina Kulinets [MicroVention Inc.]
HyperSoft 3D2016-09-16
Irina Kulinets [MicroVention Inc.]
HyperSoft 3D2016-09-16
Irina Kulinets [MicroVention Inc.]
HydroFrame 102016-09-16
Irina Kulinets [MicroVention Inc.]
HydroFrame 102016-09-16
Irina Kulinets [MicroVention Inc.]
AZUR CX Peripheral Coil System- Detachable 352015-11-09
Irina Kulinets [MicroVention Inc.]
Embolic Protection Device2015-09-18
Irina Kulinets [MicroVention Inc.]
Headway 27 Microcatheter2015-08-11
Irina Kulinets [MicroVention Inc.]
MCS & HES Coils (V-Trak Advanced)2015-08-11
Irina Kulinets [MicroVention Inc.]
MCS & HES Coils (V-Trak Advanced)2015-08-11
Irina Kulinets [MicroVention Inc.]
SOFIA Catheter2015-04-29
Irina Kulinets [MicroVention Inc.]
SOFIA Catheter2015-04-29
Irina Kulinets [MicroVention Inc.]
VFC (Line Ext)2014-10-16
Irina Kulinets [MicroVention Inc.]
Hypersoft 3D2014-10-16
Irina Kulinets [MicroVention Inc.]
Hypersoft 3D2014-10-16
Irina Kulinets [MicroVention Inc.]
SOFIA Distal Access Catheter2014-10-15
Irina Kulinets [MicroVention Inc.]
SOFIA Distal Access Catheter2014-10-15
Irina Kulinets [MicroVention Inc.]
SOFIA Distal Access Catheter2014-10-15
Irina Kulinets [MicroVention Inc.]
SOFIA Distal Access Catheter2014-10-15
Irina Kulinets [MicroVention Inc.]
LVIS Jr. Intraluminal Support Device2014-09-02
Irina Kulinets [MicroVention Inc.]
LVIS Intraluminal Support Device2014-09-02
Irina Kulinets [MicroVention Inc.]
AZUR PURE Peripheral Coil System, Pushable 182014-02-13
Irina Kulinets [MicroVention Inc.]
AZUR Pushable 18 & 35 LE2014-01-10
Irina Kulinets [MicroVention Inc.]
Azur Pure Peripheral Coil System, Pushable 352013-12-16
Irina Kulinets [MicroVention Inc.]
AZUR CX Coil System - Detachable 182012-12-04
Irina Kulinets [MicroVention Inc.]
AZUR PURE Peripheral Coil System2012-12-04
Irina Kulinets [MicroVention Inc.]
HydroFill Filar Modification2012-09-19
Irina Kulinets [MicroVention Inc.]
HydroFill Filar Modification2012-09-19
Irina Kulinets [MicroVention Inc.]
HES Adhesive2012-09-19
Irina Kulinets [MicroVention Inc.]
MicroPlex Coil System (MCS-CC)2012-09-19
Irina Kulinets [MicroVention Inc.]
AZUR Peripheral Coil System - Detachable 352012-09-06
Irina Kulinets [MicroVention Inc.]
Scepter C & XC Expanded Indications2012-09-06
Irina Kulinets [MicroVention Inc.]
Scepter C & XC Expanded Indications2012-09-06
Irina Kulinets [MicroVention Inc.]
Headway Duo Microcatheter2012-09-06
Irina Kulinets [MicroVention Inc.]
AZUR Detachable 182012-04-13
Irina Kulinets [MicroVention Inc.]
Scepter XC Occlusion Balloon Catheter2012-04-13
Irina Kulinets [MicroVention Inc.]
HydroFill (Formerly HydroSoft Plus) (Line Ext)2012-01-05
Irina Kulinets [MicroVention Inc.]
HydroFill (Formerly HydroSoft Plus) (Line Ext)2012-01-05
Irina Kulinets [MicroVention Inc.]
HydroFill (Formerly HydroSoft Plus)2011-12-06
Irina Kulinets [MicroVention Inc.]
VFC2011-12-06
Irina Kulinets [MicroVention Inc.]
Headway 272011-12-06
Irina Kulinets [MicroVention Inc.]
Scepter C Occlusion Balloon Catheter2011-12-06
Irina Kulinets [MicroVention Inc.]
Cosmos & HydroFrame 2.0 & 2.52011-12-06
Irina Kulinets [MicroVention Inc.]
Cosmos 182011-12-06
Irina Kulinets [MicroVention Inc.]
Cosmos 182011-12-06
Irina Kulinets [MicroVention Inc.]
HydroFrame 102011-12-06
Irina Kulinets [MicroVention Inc.]
HydroFrame 102011-12-06
Irina Kulinets [MicroVention Inc.]
Azur Peripheral Coil - Detachable 35 Framing2011-07-21
Irina Kulinets [MicroVention Inc.]
HydroLink Syringe Kit2010-12-08
Irina Kulinets [MicroVention Inc.]
Headway 17 Adv2010-10-13
Irina Kulinets [MicroVention Inc.]
HydroFrame 18 & 10 (Line Ext)2010-10-13
Irina Kulinets [MicroVention Inc.]
HydroFrame 18 & 10 (Line Ext)2010-10-13
Irina Kulinets [MicroVention Inc.]
Cosmos 10 (Line Ext)2010-10-13
Irina Kulinets [MicroVention Inc.]
Cosmos 182010-10-13
Irina Kulinets [MicroVention Inc.]
Headway 212010-10-13
Irina Kulinets [MicroVention Inc.]
Azur Detachable 352010-10-13
Irina Kulinets [MicroVention Inc.]
AZUR Pushable 18 Modification2010-10-13
Irina Kulinets [MicroVention Inc.]
HydroSoft-HyperSoft2010-10-13
Irina Kulinets [MicroVention Inc.]
Cosmos 182010-10-13
Irina Kulinets [MicroVention Inc.]
AZUR Detachable 18 LE2010-10-13
Irina Kulinets [MicroVention Inc.]
Headway 17 Advanced Soft2010-10-13
Irina Kulinets [MicroVention Inc.]
Cosmos 102010-10-13
Irina Kulinets [MicroVention Inc.]
HydroSoft2010-10-13
Irina Kulinets [MicroVention Inc.]
AZUR Peripheral Pushable2010-10-13
Irina Kulinets [MicroVention Inc.]
V-Trak HydroSoft2010-10-13
Irina Kulinets [MicroVention Inc.]
V-Trak HydroSoft2010-10-13
Irina Kulinets [MicroVention Inc.]
V-Trak MCS HES2010-10-13
Irina Kulinets [MicroVention Inc.]
MCS-HES2010-10-13

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