MicroVention Costa Rica S.R.L.

FDA Device Registration & Listing · . Alajuela, CR · Registration 3010079067

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010079067
FEI Number
3010079067
Entity Name
MicroVention Costa Rica S.R.L.
City/State/Country
. Alajuela, CR
Establishment Address
Zona Franca Coyol, . Alajuela ., CR
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
MicroVention Inc. (Owner Number: 10033879)
Owner / Operator Contact Address
35 Enterprise, Aliso Viejo, CA 92656, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cosmos 18 MV Flow Aspiration Pump and MV Flow Canister Woven EndoBridge (WEB) Aneurysm Embolization System WDC-2 WEB Detachment Controller AZUR Peripheral Coil System - Detachable 35 Cosmos & HydroFrame 2 & 2.5 9V V-Grip Detachment Controller SOFIA EX HydroFill Filar Modification FRED, FRED Jr., FRED X Headway 27 Microcatheter SOFIA Plus Aspiration with Tubing Kit 12V AZUR Detachment Controller Azur Detachable 35 AZUR Detachable Controller AZUR Pushable 18 Modification Scepter C & XC HydroFrame 18 & 10 (Line Ext) BOBBY Balloon Guide Catheter HyperSoft 3D Headway 17 Adv SOFIA Distal Access Catheter HydroFill (Formerly HydroSoft Plus) Cosmos 18 MicroPlex Coil System, HydroCoil Embolic System V-Trak HydroSoft VIA 17, 21, 27, 33 HydroFrame 10 AZUR CX Coil System - Detachable 18 SOFIA EX Intracranial Support Catheter AZUR PURE Peripheral Coil System, Pushable 18 AZUR Detachable 18 Azur Pure Peripheral Coil System, Pushable 35 Cosmos 10 (Line Ext) Headway 27 Headway Duo Microcatheter Headway 17 Advanced Soft HydroFill (Formerly HydroSoft Plus) (Line Ext) AZUR CX Peripheral Coil System- Detachable 35 AZUR Detachable 18 LE SOFIA Distal Access Catheter ISAAC Neurovascular Navigation Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
OPR Intrasaccular Flow Disruption Device Unknown Class 3 N/A 2019-12-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-09-06
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2011-12-06
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-09-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-06-05
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2012-09-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-09-19
OUT Intracranial Aneurysm Flow Diverter Unknown Class 3 N/A 2019-12-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-08-11
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2018-06-26
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 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
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
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 2016-09-16
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2016-09-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2014-10-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-10-15
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
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2011-12-06
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2017-06-09
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-01-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-01-20
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
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-12-04
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-01-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-01-03
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2014-02-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-04-13
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-12-16
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2010-10-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-12-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-09-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-10-13
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 2015-11-09
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2010-10-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2014-10-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-10-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-04-13
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-04-13

Official Correspondent

Scafford Serron

US Agent Details

Scafford Serron Business: Microvention Email: scafford.serron@microvention.com Phone: (949) 8670794

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
3013556777 MicroVention, Inc. Aliso Viejo, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08
K082762 Aardvark Medical AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE 2008-11-12
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0038-05 Kinetic Concepts, Inc 2
V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
Z-0035-2007 Haemonetics Corporation 2
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
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 3010079067. Last updated year: 2026. Please use registration number 3010079067 when referencing this establishment in official correspondence.
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