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Data / Medical devices / Aspiration Thrombectomy Catheter

Aspiration Thrombectomy Catheter (QEZ): 26 FDA-registered makers in 5 countries

26 establishments in 5 countries are registered with the FDA to make Aspiration Thrombectomy Catheter (product code QEZ, Class 2, 21 CFR 870.5150). 25 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 95 510(k) clearances under this code, the latest on September 3, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QEZ
Device class
2
Regulation
870.5150
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States21
Mexico2
Ireland1
India1
Japan1

Makers of Aspiration Thrombectomy Catheter

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
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer5June 6, 2012000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer5June 6, 2012000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Specification developer5June 6, 2012000api.fda.gov
Boston Scientific CorporationDorado, PR, United StatesManufacturer5June 6, 2012000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer5June 6, 2012000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesComplaint file establishment, Manufacturer4November 24, 2025000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer4November 24, 2025000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer4March 24, 2025000api.fda.gov
Control Medical TechnologySouth Salt Lake, UT, United StatesSpecification developer3May 4, 2020000api.fda.gov
Inquis Medical, Inc.Menlo Park, CA, United StatesManufacturer3July 27, 2026000api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer3April 23, 2026000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Manufacturer for export3November 3, 2021000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer3December 22, 2010000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer3December 22, 2010000api.fda.gov
Expanse Medical Inc.Pleasanton, CA, United StatesManufacturer2March 20, 2026000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoManufacturer1March 30, 2009000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer1March 30, 2009000api.fda.gov
Flowphysix, Inc.West Lake Hills, TX, United StatesSpecification developer1July 14, 2025000api.fda.gov
Meril Life Sciences Pvt. Ltd.Vapi Gujarat, IndiaComplaint file establishment, Manufacturer1April 29, 2019000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer1September 3, 2026000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer1March 28, 2008000api.fda.gov
Terumo Clinical Supply Co., Ltd.Kakamigahara Gifu, JapanManufacturer1December 14, 2011000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer1December 22, 2010000api.fda.gov
VesalioSan Diego, CA, United StatesComplaint file establishment, Specification developer1October 24, 2025000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer1November 9, 2007000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov

Updated September 3, 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.