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Data / Medical devices / United States / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Dorado, PR, United States, 9 510(k) clearances and 10 PMA approvals

Boston Scientific Corporation is registered with the FDA (registration 2648729) in Dorado, PR, United States. It lists 19 device types. The FDA files 9 510(k) clearances and 10 PMA approvals under its listings, the newest dated December 8, 2017. Registered through 2026. FDA data exported November 3, 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 makers like this oneWatch Boston Scientific Corporation
FDA registration number
2648729
Address
No. 12, RD. No. 698, Dorado, PR, United States, 00646
Owner or operator
Boston Scientific Corporation (9912058)
Roles
Manufacturer, Manufacturer for export
First device listed
November 19, 2007
Registered through
2026
Brand names listed
2x8 Contact Lead Extension Kit, 8 Contact Extension Kit, AC/DC Power Supply, ACCOLADE MRI, ACUITY STEERABLE, ACUITY Spiral, ACUITY X4 Flushing Tool/Wire Guide, ACUITY X4 Spiral and more

Devices it lists

DeviceProduct codeClassRoleSource
Aspiration Thrombectomy CatheterQEZ2Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufactureraccessdata.fda.gov
Catheter, Coronary, AtherectomyMCX3Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3Manufactureraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Manufactureraccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Manufactureraccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Manufactureraccessdata.fda.gov
Implantable Pacemaker Pulse-GeneratorDXY3Manufactureraccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Manufactureraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Manufactureraccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Manufactureraccessdata.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
September 21, 2015K151313ZelanteDVT Thrombectomy SetQEWSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 3, 2014K132914ACUITY PRO LEAD DELIVERY SYSTEMDQYSubstantially EquivalentBoston Scientificaccessdata.fda.gov
February 14, 2014K133629ANGIOJET ULTRA AVX THROMBECTOMY SETQEWSubstantially EquivalentPossis Medical, Inc.accessdata.fda.gov
July 29, 2013K130381ANGIOJET ULTRA POWER PULSE KITQEWSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
June 6, 2012K113363ANGIOJET SOLENT DISTA THROMBECTOMY SETQEZSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
May 24, 2011K111182ANGIOJET SOLENT OMNI THROMBECTOMY SETQEZSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
June 16, 2010K101406ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001QEZSubstantially EquivalentMedrad Interventional/Possisaccessdata.fda.gov
April 4, 2008K080806ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608QEZSubstantially EquivalentPossis Medical, Inc.accessdata.fda.gov
November 14, 2007K072769ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETSQEZSubstantially EquivalentPossis Medical, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
December 8, 2017P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEMNHL94October 15, 2026accessdata.fda.gov
April 25, 2016P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEADLWP186October 3, 2026accessdata.fda.gov
September 28, 2012P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEMLWS208October 2, 2026accessdata.fda.gov
April 13, 2007P050046ACUITY STEERABLE LEAD SYSTEMOJX29September 24, 2021accessdata.fda.gov
April 27, 2004P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEMLGW373September 22, 2026accessdata.fda.gov
May 2, 2002P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLLNIK580August 25, 2026accessdata.fda.gov
March 12, 1999P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETERMCX93August 1, 2025accessdata.fda.gov
October 2, 1998P960006SWEET TIP(R) RX STEROID ELUTING LEADNVN52May 15, 2026accessdata.fda.gov
November 12, 1996P960004THINLINE ENDOCARDIAL PACING LEADSNVN105June 3, 2026accessdata.fda.gov
August 26, 1993P910073ENDOTAK LEAD SYSTEMLWS179September 17, 2026accessdata.fda.gov

Compare with other makers

Updated October 15, 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.