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Data / Medical devices / Costa Rica / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in La Aurora Heredia, Costa Rica, 72 510(k) clearances and 5 PMA approvals

Boston Scientific Corporation is registered with the FDA (registration 3004859241) in La Aurora Heredia, Costa Rica. It lists 35 device types. The FDA files 72 510(k) clearances and 5 PMA approvals under its listings, the newest dated November 1, 2024. 1 recall event names it as the recalling firm. Registered through 2026. 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.

Get makers like this oneWatch Boston Scientific Corporation
FDA registration number
3004859241
Address
302 Parkway, Global Park, La Aurora Heredia, Costa Rica, --
Owner or operator
Boston Scientific Corporation (9912058)
Roles
Manufacturer, Specification developer
First device listed
September 9, 1983
Registered through
2026
Brand names listed
Blazer II HTD Temperature Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II XP Temperature Ablation Catheter, Blazer Open-Irrigated Ablation Catheter, Blazer Prime HTD Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, Blazer Solid-Tip Ablation Cather Cable, Sterile Cable, Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, CatheterKGZ1Specification developeraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Specification developeraccessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine FibroidsNAJ2Specification developeraccessdata.fda.gov
Cable, ElectrodeIKD2Manufactureraccessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)DSA2Manufactureraccessdata.fda.gov
Cardiac Ablation Percutaneous CatheterLPB3Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufacturer, Specification developeraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Specification developeraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Specification developeraccessdata.fda.gov
Catheter, NephrostomyLJEUSpecification developeraccessdata.fda.gov
Catheter, Nephrostomy, General & Plastic SurgeryGBO1Specification developeraccessdata.fda.gov
Catheter, PercutaneousDQY2Specification developeraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD3Manufactureraccessdata.fda.gov
Catheter, Peripheral, AtherectomyMCW2Manufactureraccessdata.fda.gov
Catheter, PeritonealGBW1Specification developeraccessdata.fda.gov
Catheter, SteerableDRA2Manufactureraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Specification developeraccessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-UrologyOCY2Manufactureraccessdata.fda.gov
Intracranial Neurovascular StentNJEfSpecification developeraccessdata.fda.gov
Needle, CatheterGCB1Specification developeraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Manufactureraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Manufactureraccessdata.fda.gov
Radiographic Protective GloveIWP1Specification developeraccessdata.fda.gov
Stent, UreteralFAD2Specification developeraccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Specification developeraccessdata.fda.gov
Stylet For Catheter, Gastro-UrologyEZB1Manufactureraccessdata.fda.gov
Syringe, Balloon InflationMAV2Specification developeraccessdata.fda.gov
Syringe, Balloon Inflation, ExemptPTM2Specification developeraccessdata.fda.gov
Temporary Carotid Catheter For Embolic CaptureNTE2Specification developeraccessdata.fda.gov
Temporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionNFA2Specification developeraccessdata.fda.gov
Tube, Drainage, SuprapubicFFA2Specification developeraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufacturer, Specification developeraccessdata.fda.gov
Wire, Guide, Catheter, ExemptPTL2Specification 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, 2024K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 27, 2023K233207Polaris X™ Unidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
September 29, 2023K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 27, 2023K230706EMBOLD™ Soft Detachable Coil SystemKRDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 25, 2023K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableDRFSubstantially EquivalentBoston Scientificaccessdata.fda.gov
March 22, 2023K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorDRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
November 10, 2022K211934APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenbergFADUnknownBoston Scientific Corporationaccessdata.fda.gov
September 6, 2022K220962ROTAPRO Rotational Atherectomy SystemMCWSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 10, 2022K220796IntellaMap Orion High Resolution Mapping CatheterDRFSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
April 12, 2022K213398EMBOLD Fibered Detachable Coil SystemKRDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 2, 2020K202218ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation DeviceQEWSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 28, 2020K201792TRUSELECT MicrocatheterKRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 2, 2020K191446Ureteral Stent Systems, Biliary Drainage CathetersFADUnknownBoston Scientific Corporationaccessdata.fda.gov
September 26, 2018K182315Magic Torque DLVR GuidewireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 18, 2018K180726Savion DLVR Guidewire, Savion FLX GuidewireDQXSubstantially EquivalentBoston Scientific, Inc.accessdata.fda.gov
April 12, 2018K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQXSubstantially EquivalentBoston Scientificaccessdata.fda.gov
November 9, 2017K172453WATCHDOG Hemostasis Valve KitDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
May 16, 2017K163701Direxion and Direxion HI-FLO Torqueable MicrocathetersKRASubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 22, 2017K170636Fathom-16 Steerable GuidewiresDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 6, 2017K162253Trapper Exchange DeviceDQYSubstantially EquivalentCreganna Medical Aslo Business AS Cregganna Tactx Medicalaccessdata.fda.gov
February 12, 2016K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
December 16, 2015K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension WireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 29, 2015K152605Impulse Angiographic Catheter, Expo Angiographic CatheterDQOSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
January 15, 2015K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix WireDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
October 8, 2014K141378IDC INTERLOCKING DETACHABLE COILKRDSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
July 22, 2014K140273EQUALIZER OCCLUSION BALLOON CATHETERMJNSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
May 15, 2014K140329RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KITKRASubstantially EquivalentBoston Scientificaccessdata.fda.gov
April 17, 2014K140745ENCORE 26 ADVANTAGE KITMAVUnknownBoston Scientific Corpaccessdata.fda.gov
November 14, 2013K133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMKRDSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
October 22, 2013K132990OCCLUSION BALLOON CATHETERMJNSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
September 13, 2013K132578INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEMKRDSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
September 13, 2012K121774ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUSMCWSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
May 21, 2012K120495IMPULSE AND EXPO ANGIOGRAPHIC CATHETERDQOSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
October 18, 2011K112745V-14 CONTROL WIRE GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
June 30, 2011K111498FATHOM (TM) 14 STEERABLE GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
April 8, 2011K110479ACUITY WHISPER VIEW GUIDE WIRESDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
February 11, 2011K102714COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICALKRDSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
April 16, 2010K100663CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321NAJSubstantially EquivalentBoston Scientific Corporationaccessdata.fda.gov
March 5, 2010K093969ACUITY BREAK-AWAY GUIDE CATHETERDQYSubstantially EquivalentCardiac Pacemakers, Inc.accessdata.fda.gov
July 2, 2009K090554ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
December 5, 2006K063313FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)NTESubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
August 11, 2006K061332FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)NFASubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
January 12, 2004K033742BOSTON SCIENTIFIC V-18 CONTROL WIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
November 21, 2003K033441BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETERDQYSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
May 21, 2003K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIREDQXSubstantially EquivalentBoston Scientific Scimed, Inc.accessdata.fda.gov
December 20, 2002K023870FLEXIMA BILIARY CATHETERFGESubstantially EquivalentBoston Scientific/Medi-Techaccessdata.fda.gov
November 26, 2002K023681RENEGADE STC 18 MICROCATHETERDQOSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
October 16, 2002K022357TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815DQXSubstantially EquivalentBoston Scientific, Targetaccessdata.fda.gov
February 11, 2002K020283BACK-UP MEIER STEERABLE GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
January 29, 2002K020012MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETERDQOSubstantially EquivalentBoston Scientific/Medi-Techaccessdata.fda.gov
January 22, 2002K0200286F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXXDQYSubstantially EquivalentBoston Scientificaccessdata.fda.gov
January 11, 2002K013598REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLESDSASubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
April 18, 2001K010853GUIDER SOFTIP GUIDING CATHETER XF 5FDQYSubstantially EquivalentBoston Scientific, Targetaccessdata.fda.gov
April 7, 2000K000177RENEGADE HI-FLO MICROCATHETERKRASubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
November 5, 1999K992373ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLEDRFSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
August 11, 1998K980453SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSDQYSubstantially EquivalentBoston Scientific Scimed, Inc.accessdata.fda.gov
November 19, 1997K973645RENEGADE FIBER BRAIDED MICROCATHETERKRASubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
October 23, 1997K971265VIKING DIAGNOSTIC ELECTRODE CATHETERDRFSubstantially EquivalentC.R. Bard, Inc.accessdata.fda.gov
July 1, 1997K971254TRANSEND EX PLATINUM GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
January 28, 1997K964611TRANSEND GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
June 5, 1995K945379PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATINGDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
February 8, 1995K944677SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIESDQXSubstantially EquivalentScimed Peripheral Interventionsaccessdata.fda.gov
December 8, 1994K942453GUIDE WIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
September 1, 1994K941710SCIMED TRANSEND STEERABLE GUIDE WIRE AND ACCESSORIESDQXSubstantially EquivalentScimed Peripheral Interventionsaccessdata.fda.gov
June 17, 1994K935997PLATINUM PLUS GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
January 26, 1994K933334MAGIC TORQUE GUIDEWIREDQXSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
January 26, 1994K924608HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERSFGESubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
October 7, 1993K934122SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIESDQXSubstantially EquivalentScimed Peripheral Interventionsaccessdata.fda.gov
September 3, 1993K924163EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELECDRFSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
November 25, 1991K913871FLOSWITCH(R) HPDQOSubstantially EquivalentBoston Scientific Corpaccessdata.fda.gov
November 29, 1984K843012WIREGUIDE OR GUIDEWIREDQXSubstantially EquivalentMedi-Tech, Inc.accessdata.fda.gov
June 2, 1981K811378PERCUTANEOUS DRAINING CATHETERGBWSubstantially EquivalentMedi-Tech, Inc.accessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
January 30, 2024P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,QZI24October 2, 2026accessdata.fda.gov
August 8, 2023P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, AccessoriesOAE12May 29, 2026accessdata.fda.gov
February 24, 2016P150005BLAZER OPEN-IRRIGATED ABLATION CATHETEROAD91December 5, 2025accessdata.fda.gov
August 25, 2003P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEMOAD141October 17, 2025accessdata.fda.gov
October 28, 1994P920047EPT-1000 CARDIAC ABLATION SYSTEMLPB133October 17, 2025accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 28, 201881747Class IIIOngoingBlazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiologiSupplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.accessdata.fda.gov

Compare with other makers

Updated October 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.