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Data / Medical devices / Temporary Carotid Catheter For Embolic Capture

Temporary Carotid Catheter For Embolic Capture (NTE): 16 FDA-registered makers in 4 countries

16 establishments in 4 countries are registered with the FDA to make Temporary Carotid Catheter For Embolic Capture (product code NTE, Class 2, 21 CFR 870.1250). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on April 27, 2023, and lists 7 recall events (3 Class I). FDA data exported November 2, 2026.

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Get every maker of this deviceMakers in the United StatesWatch this device
Product code
NTE
Device class
2
Regulation
870.1250
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States11
Costa Rica3
Israel1
Mexico1

Makers of Temporary Carotid Catheter For Embolic Capture

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
ev3, Inc.Plymouth, MN, United StatesManufacturer, Specification developer3October 27, 2011000api.fda.gov
Cardiovascular Systems IncorporatedSaint Paul, MN, United StatesComplaint file establishment, Manufacturer2March 3, 2021011api.fda.gov
ProCatid Medcial LtdCaesarea Northern, IsraelManufacturer2March 21, 2018000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Manufacturer1July 25, 2019010api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer1July 25, 2019000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer1December 5, 2006000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer1April 11, 2023021api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer1December 5, 2006000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1April 11, 2023000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer1April 6, 2022011api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer1October 15, 2009000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer1April 27, 2023000api.fda.gov
Contego Medical, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCQueensbury, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov

Updated April 27, 2023. 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.