Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013556777

FEI Number

3013556777

Entity Name

MicroVention, Inc.

City/State/Country

Aliso Viejo, CA, US

Establishment Address

35 Enterprise, Aliso Viejo, CA 92656, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MicroVention Inc. (Owner Number: 10033879)

Owner / Operator Contact Address

35 Enterprise, Aliso Viejo, CA 92656, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111451

PMA Number

N/A

All Registered Proprietary Names

Traxcess 14EX Guidewire Traxcess 7 Mini Guidewire Headway 17 Advanced Soft Wedge HydroFrame 18 & 10 (Line Ext) Azur Pure Peripheral Coil System, Pushable 35 EmPro Embolic Protection System Nanoparasol Embolic Protection System Headway Duo Microcatheter MCS & HES Coils (V-Trak Advanced) AZUR PURE Peripheral Coil System, Pushable 18 SOFIA Distal Access Catheter AZUR CX Coil System - Detachable 18 Headway 17 Adv MicroPlex Coil System, HydroCoil Embolic System MicroVention Tubing Kit LifePearl VFC (Line Ext) LVIS, LVIS Jr., LVIS EVO Headway 27 Microcatheter ERIC Traxcess 14 Guidewire SOFIA 88 Catheter HydroFrame 10 SOFIA EX V-Trak MCS HES 12V V-Grip Detachment Controller Scepter Mini Occlusion Balloon Catheter Traxcess 7 Mini Guidewire Cosmos 18 SOFIA Catheter AZUR Detachable 18 LE MV Flow Aspiration Pump and MV Flow Canister Cosmos & HydroFrame 2 & 2.5 Headway 27 V-Trak HydroSoft Cosmos 10 (Line Ext) Scepter C & XC AZUR HydroPack HyperSoft 3D SOFIA EX Intracranial Support Catheter HydroSoft Cosmos 10 Traxcess 14 SELECT Guidewire Cosmos 18 CASPER Carotid Stent System Roadsaver Carotid Stent System VIA 17, 21, 27, 33 AZUR Vascular Plug AZUR CX Detachable 18 Peripheral Coil System Wedge XL Delivery Catheter Precipitating Hydrophobic Injectable Liquid (PHIL Liquid Embolic System) BOBBY Balloon Guide Catheter HydroFill (Formerly HydroSoft Plus) (Line Ext) AZUR Peripheral Coil System - Detachable 35 Headway 21 Cosmos 18 Traxcess Docking Wire HydroSoft Woven EndoBridge (WEB) Aneurysm Embolization System WDC-2 WEB Detachment Controller FRED, FRED Jr., FRED X Hypersoft 3D AZUR Pushable 18 Modification Azur Peripheral Coil - Detachable 35 Framing ISAAC Neurovascular Navigation Catheter AZUR Detachable 18 Chaperon VFC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-10-13
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2020-07-17
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-07-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2010-10-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-12-16
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2025-04-25
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-09-06
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2015-08-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2015-08-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-02-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2014-10-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-10-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-12-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-06-09
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2017-12-18
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-03-24
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2014-10-16
QCA	Intracranial Coil-Assist Stent	Unknown	Class 3	N/A	2018-06-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-08-11
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2022-04-18
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2014-08-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-08-14
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-10-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-10-14
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-12-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-12-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-06-05
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-01-20
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2016-11-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-11-29
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2015-04-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2015-04-29
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-12-11
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-12-11
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-12-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-12-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2012-09-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-09-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-04-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2016-09-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2016-09-16
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-01-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-01-03
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2020-05-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-05-08
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-12-06
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-12-06
NIM	Stent, Carotid	Unknown	Class 3	N/A	2025-04-07
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-01-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-01-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2020-05-08
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-03-06
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-06-25
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2016-08-23
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2020-07-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-07-21
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-01-05
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-01-05
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-09-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2010-10-13
OPR	Intrasaccular Flow Disruption Device	Unknown	Class 3	N/A	2019-12-19
OUT	Intracranial Aneurysm Flow Diverter	Unknown	Class 3	N/A	2019-12-19
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-10-16
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2014-10-16
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2010-10-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-07-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-04-13
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-04-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-04-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-10-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-12-06

Official Correspondent

Scafford Serron

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MicroVention Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010079067	MicroVention Costa Rica S.R.L.	. Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013556777. Last updated year: 2026. Please use registration number 3013556777 when referencing this establishment in official correspondence.