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Data / Medical devices / Catheter, Septostomy

Catheter, Septostomy (DXF): 18 FDA-registered makers in 3 countries

18 establishments in 3 countries are registered with the FDA to make Catheter, Septostomy (product code DXF, Class 2, 21 CFR 870.5175). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on June 26, 2026, and lists 4 recall events (2 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
DXF
Device class
2
Regulation
870.5175
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States13
Canada3
Costa Rica2

Makers of Catheter, Septostomy

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
Atraverse MedicalSolana Beach, CA, United StatesComplaint file establishment, Specification developer3February 27, 2026000api.fda.gov
Atraverse MedicalCardiff by the Sea, CA, United StatesComplaint file establishment, Specification developer3February 27, 2026000api.fda.gov
Boston Scientific CorporationCartago, Costa RicaManufacturer3November 1, 2024000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3November 1, 2024000api.fda.gov
Boston Scientific CorporationMississauga Ontario, CanadaManufacturer, Specification developer3November 1, 2024000api.fda.gov
CIRCA Scientific, Inc.Englewood, CO, United StatesSpecification developer3May 1, 2025000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2June 17, 2015000api.fda.gov
Baylis Medical Technologies Inc.Mississauga Ontario, CanadaComplaint file establishment, Manufacturer1February 1, 2001000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1July 28, 1980000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesManufacturer1August 22, 2022011api.fda.gov
Electrowire Corporation Dba Electrowire MedicalLexington, SC, United StatesManufacturer1June 26, 2026000api.fda.gov
Numed Canada, Inc.CORNWALL Ontario, CanadaManufacturer1July 19, 2021000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer1July 19, 2021000api.fda.gov
Pressure Products Medical Device Manufacturing LLCMorton, PA, United StatesManufacturer1March 13, 2026000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov

Updated June 26, 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.