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Data / Medical devices / Catheter For Crossing Total Occlusions

Catheter For Crossing Total Occlusions (PDU): 21 FDA-registered makers in 5 countries

21 establishments in 5 countries are registered with the FDA to make Catheter For Crossing Total Occlusions (product code PDU, Class 2, 21 CFR 870.1250). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 58 510(k) clearances under this code, the latest on August 28, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

Makers by country

CountryMakers
United States16
Germany2
Canada1
Mexico1
Costa Rica1

Makers of Catheter For Crossing Total Occlusions

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
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesSpecification developer3August 12, 2021010api.fda.gov
Baylis Medical Technologies Inc.Mississauga Ontario, CanadaComplaint file establishment, Manufacturer3September 11, 2025000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer3May 19, 2015000api.fda.gov
LimFlow Inc.Irvine, CA, United StatesSpecification developer2May 31, 2025000api.fda.gov
AngioSafeSan Jose, CA, United StatesManufacturer1September 22, 2025000api.fda.gov
Bentley Innomed GMBHHechingen Baden-Wurttemberg, GermanySpecification developer1March 1, 2022000api.fda.gov
Reflow Medical, IncSan Clemente, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1August 28, 2026000api.fda.gov
Reflow MedicalLake Forest, CA, United StatesManufacturer, Repackager or relabeler1August 28, 2026000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer1July 11, 2007000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer1December 2, 2016010api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer1December 2, 2016000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer1May 22, 2012000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Contract Medical International GmbHDRESDEN Saxony, GermanyContract manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.fda.gov

Updated August 28, 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.