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Data / Medical devices / Dilator, Vessel, For Percutaneous Catheterization / United States

FDA-registered makers of Dilator, Vessel, For Percutaneous Catheterization in the United States: 33 establishments

33 establishments in the United States are registered with the FDA to make Dilator, Vessel, For Percutaneous Catheterization (product code DRE). 20 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Dilator, Vessel, For Percutaneous Catheterization
Product code
DRE
Country
United States

Makers of Dilator, Vessel, For Percutaneous Catheterization in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer12July 27, 2026040api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer5April 6, 2021000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3July 12, 2024000api.fda.gov
Cook Vandergrift Inc.Vandergrift, PA, United StatesComplaint file establishment, Manufacturer3November 12, 2014000api.fda.gov
Galt Medical Corp.Garland, TX, United StatesComplaint file establishment, Manufacturer3September 26, 2019030api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer3July 8, 2016000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2September 27, 2013010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler2March 11, 1997051api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2September 27, 2013000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 1, 2017000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesComplaint file establishment, Contract sterilizer, Manufacturer1July 1, 2014000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer1April 24, 1997020api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer1August 19, 1986000api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer1April 13, 2010000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesContract manufacturer, Contract sterilizer, Manufacturer1October 24, 2007000api.fda.gov
MC3, Inc.Dexter, MI, United StatesManufacturer1October 29, 2018000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer1August 19, 1986000api.fda.gov
Mermaid Medical A/S (FL Site)University Park, FL, United StatesComplaint file establishment, Specification developer1October 31, 2007000api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer1April 11, 1981010api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesSpecification developer1September 12, 1989000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
NeedleTech Products, Inc.N Attleboro, MA, United StatesContract manufacturer0000api.fda.gov
Nordson MEDICAL (CA), LLCHuntingtn Bch, CA, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Protaryx Medical, LLCBaltimore, MD, United StatesManufacturer0000api.fda.gov
Spectrum VascularWarren, NJ, 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.