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Data / Medical devices / Canada / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Mississauga Ontario, Canada, 22 510(k) clearances

Boston Scientific Corporation is registered with the FDA (registration 3019751610) in Mississauga Ontario, Canada. It lists 10 device types. The FDA files 22 510(k) clearances under its listings, the newest dated November 1, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Boston Scientific Corporation
FDA registration number
3019751610
Address
2775 Matheson Blvd E, Mississauga Ontario, Canada, L4W 4P7
Owner or operator
Boston Scientific Corporation (9912058)
Roles
Manufacturer, Specification developer
First device listed
August 27, 1992
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Cable, ElectrodeIKD2Manufacturer, Specification developeraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, SeptostomyDXF2Manufacturer, Specification developeraccessdata.fda.gov
Dilator, Vessel, For Percutaneous CatheterizationDRE2Manufacturer, Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Specification developeraccessdata.fda.gov
Introducer, CatheterDYB2Manufacturer, Specification developeraccessdata.fda.gov
Percutaneous Atrial Catheter KitOFK2Manufacturer, Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 1, 2024K242076VersaCross™ RF WireDXFSubstantially EquivalentBaylis Medical Companyaccessdata.fda.gov
July 12, 2024K241720VersaCross Connect™ Transseptal DilatorDRESubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
December 20, 2023K231227SureFlex HD Steerable Sheath, VersaCross HD Steerable SheathDYBSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
December 14, 2023K233647VersaCross Connect™ Transseptal DilatorDRESubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
December 19, 2022K221351Mechanical GuidewireDQXSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
June 30, 2022K213582Epicardial Access SystemDYBSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
May 9, 2022K220414VersaCross Connect Transseptal DilatorDYBSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
June 12, 2020K201288ExpanSure Large Access Transseptal DilatorDRESubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
June 7, 2019K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRFSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
June 7, 2019K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRFSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
May 20, 2019K183655VersaCross Transseptal SheathDYBSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
April 17, 2019K190688VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYBSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
March 21, 2019K182064ExpanSure Transseptal Dilation SystemDRESubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
June 17, 2015K150709ProTrack RF Anchor WireDXFSubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
September 4, 2014K141831HYDRAVIEW GUIDEWIREDQXSubstantially EquivalentBrivant Limitedaccessdata.fda.gov
January 24, 2013K122926SUREFLEX STEERABLE GUIDING SHEATH KITDYBSubstantially EquivalentBaylis Medical Co., Inc.accessdata.fda.gov
November 7, 2012K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATORGEISubstantially EquivalentBaylis Medical Company, Inc.accessdata.fda.gov
August 2, 2011K111288ANCHORWIRE GUIDEWIREDQXSubstantially EquivalentLake Region Medicalaccessdata.fda.gov
April 1, 2011K102948TORFLEX TRANSSEPTAL GUIDING SHEATHDYBSubstantially EquivalentBaylis Medical Co., Inc.accessdata.fda.gov
May 28, 2008K073326NRG TRANSSEPTAL NEEDLEDXFSubstantially EquivalentBaylis Medical Co., Inc.accessdata.fda.gov
December 31, 2002K023334BMC CATHETER CONNECTOR CABLE, MODEL RFP-101DSASubstantially EquivalentBaylis Medical Co., Inc.accessdata.fda.gov
February 12, 2002K013904BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230GEISubstantially EquivalentBaylis Medical Co., Inc.accessdata.fda.gov

Compare with other makers

Updated November 1, 2024. 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.