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Data / Medical devices / Guide, Wire, Catheter, Neurovasculature

Guide, Wire, Catheter, Neurovasculature (MOF): 28 FDA-registered makers in 10 countries

28 establishments in 10 countries are registered with the FDA to make Guide, Wire, Catheter, Neurovasculature (product code MOF, Class 2, 21 CFR 870.1330). 19 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on September 16, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MOF
Device class
2
Regulation
870.1330
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States13
China5
Japan2
Switzerland2
Israel1
Thailand1
Vietnam1
France1
Ireland1
Philippines1

Makers of Guide, Wire, Catheter, Neurovasculature

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Asahi Intecc Co., Ltd.SETO Aichi, JapanManufacturer, Specification developer10February 2, 2026000api.fda.gov
Scientia VascularWest Valley City, UT, United StatesManufacturer6August 6, 2026000api.fda.gov
Arbor EndovascularSan Jose, CA, United StatesComplaint file establishment, Specification developer5August 14, 2026000api.fda.gov
Deepintec Scientific Co., LtdBeijing, ChinaManufacturer4March 19, 2026000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Repackager or relabeler, Specification developer4July 2, 2020010api.fda.gov
Rapid-Medical Ltdyokneam Northern, IsraelComplaint file establishment, Manufacturer3July 17, 2026000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesSpecification developer2September 25, 2020010api.fda.gov
Stryker NeurovascularSalt Lake City, UT, United StatesManufacturer2September 25, 2020000api.fda.gov
Artiria Medical SAGeneva Geneve, SwitzerlandManufacturer1April 24, 2023000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesManufacturer1October 4, 2018000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer1February 24, 2014000api.fda.gov
Cerenovus, Inc.Raynham, MA, United StatesManufacturer1February 24, 2014000api.fda.gov
Enlight Medical Technologies (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1November 18, 2024000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer1August 26, 2025000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1February 24, 2014000api.fda.gov
Piraeus Medical, Inc.Maple Grove, MN, United StatesManufacturer1August 27, 2026000api.fda.gov
Shanghai Achieva Medical Suzhou Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1March 16, 2026000api.fda.gov
Suzhou Zenith Vascular Scitech LimitedSuzhou Jiangsu, ChinaManufacturer1April 16, 2026000api.fda.gov
Terumo Medical Products (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1June 29, 2022000api.fda.gov
Asahi Intecc (thailand) Co., Ltd.Amphur Muang Pathumthani Pathum Thani, ThailandContract manufacturer0000api.fda.gov
Asahi Intecc Hanoi Co., Ltd.Hanoi Ha Noi, VietnamContract manufacturer0000api.fda.gov
Balt ExtrusionMONTMORENCY Val-d'Oise, FranceContract manufacturer0000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer0000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer0000api.fda.gov
NeedleTech Products, Inc.N Attleboro, MA, United StatesContract manufacturer0000api.fda.gov
Phenox LimitedGalway Galway(County), IrelandManufacturer0000api.fda.gov
Toyoflex Cebu CorporationLapu-Lapu Cebu(Province), PhilippinesContract manufacturer0000api.fda.gov
Yokowo Co., LtdTomioka Gunma, JapanContract manufacturer0000api.fda.gov

Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.