# MicroVention, Inc.

- Location (FDA's records): Tistin, CA
- FDA decisions: 90 (2001–2025): 86 510(k) clearances and 4 original PMA approvals
- Names in FDA's records: MicroVention, Inc. (89); Microvention (1)
- Product codes: HCG (32), KRD (18), DQY (16), MOF (6), MJN (3), DQX (3), QJP (2), NRY (2), NTE (1), QCA (1), OPR (1), OUT (1)
- 510(k) review time since 2016: median 176 days, against 109 for FDA's reviews in the same codes and years (4 of 22 faster)
- Predicates its devices cite: 159 (121 its own); citations of its devices by later devices: 153 (121 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific, Target: 8 (https://510kreport.com/company/boston-scientific-target)
- Terumo Medical Corp.: 4 (https://510kreport.com/company/terumo-medical)
- Concentric Medical, Inc.: 4 (https://510kreport.com/company/concentric-medical)
- Biosphere Medical, S.A.: 3 (https://510kreport.com/company/biosphere-medical)
- Sequent Medical, Inc.: 3 (https://510kreport.com/company/sequent-medical)
- Micrus Corp.: 3 (https://510kreport.com/company/micrus)
- Penumbra, Inc.: 3 (https://510kreport.com/company/penumbra)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Reverse Medical Corporation: 4 (https://510kreport.com/company/reverse-medical)
- Guangzhou Easycess Medical Co.,Ltd: 3 (https://510kreport.com/company/guangzhou-easycess-medical)
- Balt USA, LLC: 3 (https://510kreport.com/company/balt-usa)
- Blockade Medical: 2 (https://510kreport.com/company/blockade-medical)
- Sequent Medical, Inc.: 2 (https://510kreport.com/company/sequent-medical)
- Cerus Endovascular, Inc.: 2 (https://510kreport.com/company/cerus-endovascular)
- MicroVention, Inc., d/b/a Terumo Neuro: 2 (https://510kreport.com/company/microvention-d-b-a-terumo-neuro)
- Anoxia Medical, Inc.: 1 (https://510kreport.com/company/anoxia-medical)

## Its most-cited devices
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) (2005), cited by 9
- K083343: Headway 17 Microcatheter (2008), cited by 6
- K071939: Hydrocoil Embolic Systems (Hes) (2008), cited by 6
- K093160: Headway 21 Microcatheter, Model: MC212150S (2009), cited by 5
- K090891: Microplex Coil System-Cosmos (2009), cited by 5
- K131482: Sofia Distal Access Catheter (2013), cited by 4

## Recent decisions
- K243638: MV Flow Aspiration Pump (MVFLOWPMP01) (Jun 13, 2025)
- P210030: Roadsaver/CASPER Carotid Stent Device (Nov 20, 2024)
- K232542: Wedge XL Delivery Catheter (May 16, 2024)
- K230775: SOFIA EX Intracranial Support Catheter (Sep 14, 2023)
- K222694: EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) (Apr 27, 2023)
- K222115: ISAAC Neurovascular Navigation Catheter (Jan 10, 2023)
- K223050: AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (Dec 21, 2022)
- K214024: SOFIA 88 Catheter (Sep 12, 2022)

Source page: https://510kreport.com/company/microvention