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Data / Medical devices / Catheter, Flow Directed / United States

FDA-registered makers of Catheter, Flow Directed in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Catheter, Flow Directed (product code DYG). 14 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Flow Directed
Product code
DYG
Country
United States

Makers of Catheter, Flow Directed in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer19December 9, 2024010api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer18June 27, 2024010api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)Chelmsford, MA, United StatesManufacturer4September 26, 1989000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesManufacturer, Specification developer3May 25, 1988000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer2August 12, 1984000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler1April 29, 1982000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1January 30, 1984020api.fda.gov
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer1December 3, 1985000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesSpecification developer1May 25, 1988000api.fda.gov
Lemaitre Vascular, Inc.Burlington, MA, United StatesManufacturer1June 30, 1981010api.fda.gov
LeMaitre Vascular Inc.Billerica, MA, United StatesManufacturer1June 30, 1981000api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer1August 28, 2001000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer1August 28, 2001000api.fda.gov
Oscor Inc.Palm Harbor, FL, United StatesComplaint file establishment, Manufacturer1June 18, 2008000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0020api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Liquet Medical Inc.Glen Allen, VA, United StatesSpecification developer0000api.fda.gov

Updated November 2, 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.