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Data / Medical devices / Catheter, Steerable / United States

FDA-registered makers of Catheter, Steerable in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Catheter, Steerable (product code DRA). 13 have a 510(k) clearance or PMA approval on file and 3 have a recall event. 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.

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Device
Catheter, Steerable
Product code
DRA
Country
United States

Makers of Catheter, Steerable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer4October 31, 2023010api.fda.gov
Abbott VascularMenlo Park, CA, United StatesManufacturer3September 28, 2022000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer2May 29, 2019000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesSpecification developer2September 28, 2022000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesManufacturer, Specification developer2December 11, 2023021api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2December 11, 2023000api.fda.gov
Abbott MedicalWestfield, IN, United StatesManufacturer1May 29, 2019000api.fda.gov
Cardiofocus, Inc.Marlborough, MA, United StatesManufacturer, Specification developer1February 24, 2016000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1January 27, 1984010api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer1February 24, 2016000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1January 27, 1984000api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer1January 26, 1993000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer1January 26, 1993000api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer0000api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesManufacturer for export0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer for export0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer for export0000api.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.