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Data / Medical devices / Ireland / Medtronic Ireland

Medtronic Ireland: FDA-registered device maker in GALWAY Galway(County), Ireland, 30 510(k) clearances and 14 PMA approvals

Medtronic Ireland is registered with the FDA (registration 9612164) in GALWAY Galway(County), Ireland. It lists 21 device types. The FDA files 30 510(k) clearances and 14 PMA approvals under its listings, the newest dated October 29, 2025. 4 recall events name it as the recalling firm (1 Class I). 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 Medtronic Ireland
FDA registration number
9612164
FEI number
3002806434
Address
Parkmore Business Park West, GALWAY Galway(County), Ireland, --
Owner or operator
Medtronic, Inc. (2112641)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 7, 2007
Registered through
2026
Brand names listed
ARES Antibiotic Impregnated Catheters, Affera™ Ablation System, Attain 6216A and 6218A Guide Catheters for Left Heart Delivery, Attain 6227DEF, Attain Access 6218A Left Heart Delivery System, Attain Clarity 6225 Venogram Balloon Catheter, Attain Command + SureValve Delivery System, Attain Command + SureValve Guide Catheter for Left-Heart Delivery and more

Devices it lists

DeviceProduct codeClassRoleSource
Ablation Catheter, Renal DenervationQYI3Manufactureraccessdata.fda.gov
Agent, Occluding, Vascular, PermanentPJQ3Manufactureraccessdata.fda.gov
Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.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, SteerableDRA2Manufactureraccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Specification developeraccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Manufactureraccessdata.fda.gov
Drug-Coated Peripheral Transluminal Angioplasty CatheterPRC3Manufactureraccessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU3Manufactureraccessdata.fda.gov
Endovascular Suturing SystemOTD2Manufactureraccessdata.fda.gov
Introducer, CatheterDYB2Specification developeraccessdata.fda.gov
Leadless PacemakerPNJ3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Manufactureraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Manufactureraccessdata.fda.gov
Pulmonary Valve Prosthesis Percutaneously DeliveredNPVfManufactureraccessdata.fda.gov
Shunt, Central Nervous System And ComponentsJXG2Manufactureraccessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm TreatmentMIH3Manufactureraccessdata.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
October 29, 2025K252390Telescope Guide Extension CatheterDQYSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
June 11, 2025K250787Liberant Thrombectomy SystemQEWSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
March 27, 2025K250558SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)DQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 31, 2023K232321FlexCath Contour™ Steerable SheathDRASubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
November 7, 2022K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery systemDQYSubstantially EquivalentMedtronicaccessdata.fda.gov
August 24, 2021K212027TurboHawk Plus Directional Atherectomy SystemMCWSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
August 3, 2020K192712Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery CatheterDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 22, 2019K183353Telescope Guide Extension CatheterDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 15, 2019K183493SelectSite C304-HIS Deflectable Catheter SystemDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
November 21, 2018K182957Heli-FX EndoAnchor SystemOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
June 16, 2017K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCWSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
June 13, 2017K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
October 14, 2016K161361HawkOne Directional Atherectomy SystemMCWSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
August 7, 2015K152054Confida Adaptive SheathDYBSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
April 2, 2015K143480Euphora Rapid Exchange Balloon Dilatation CatheterLOXSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 16, 2014K141801HAWKONE DIRECTIONAL ATHERECTOMY SYSTEMMCWSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
August 15, 2014K141090NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETERLOXSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
April 9, 2013K123153ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECTDQYSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
September 25, 2012K121219ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETERDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
November 18, 2011K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERJXGSubstantially EquivalentMedtronic Neurosurgeryaccessdata.fda.gov
October 27, 2011K112917ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUIDDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
January 5, 2011K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMMCWSubstantially EquivalentEv3, Inc.accessdata.fda.gov
October 22, 2010K103095SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOONLOXSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
September 9, 2010K101885MEDTRONIC C315 DELIVERY CATHETERDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 26, 2009K090659ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERYDQYSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
October 25, 2006K061416SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74DQYSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
October 23, 2006K061188SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCWSubstantially EquivalentFoxhollow Technologies, Inc.accessdata.fda.gov
August 21, 2006K061480ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEMDQYSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
March 16, 2006K053431ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEMDQYSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
April 13, 2005K050038RELIANT STENT GRAFT BALLOON CATHETERDQYSubstantially EquivalentMedtronic Endovascular Innovationsaccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
October 24, 2024P240013Sphere-9 Catheter and Affera Ablation SystemQZI32October 9, 2026accessdata.fda.gov
December 13, 2023P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI11June 30, 2026accessdata.fda.gov
November 17, 2023P220026Symplicity Spyral™ Renal Denervation SystemQYI17October 23, 2026accessdata.fda.gov
March 26, 2021P200046Harmony™ TPV SystemNPV51September 30, 2026accessdata.fda.gov
January 28, 2021P200028DiamondTemp Ablation SystemOAE24October 10, 2025accessdata.fda.gov
November 21, 2019P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon CatheterPRC46May 21, 2026accessdata.fda.gov
April 28, 2017P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ88October 16, 2026accessdata.fda.gov
April 6, 2016P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ225September 8, 2026accessdata.fda.gov
February 20, 2015P140018VENASEAL CLOSURE SYSTEMPJQ47October 15, 2026accessdata.fda.gov
December 30, 2014P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU97September 24, 2026accessdata.fda.gov
January 17, 2014P130021MEDTRONIC COREVALVE SYSTEMNPT182August 10, 2026accessdata.fda.gov
April 1, 2011P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH69February 27, 2026accessdata.fda.gov
December 16, 2010P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH129May 12, 2026accessdata.fda.gov
March 24, 1980P790017USCI DILATATION CATHETERLOX86October 27, 2010accessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
May 12, 202085649Class ITerminatedMedtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)accessdata.fda.gov
September 3, 201983797Class IIOngoingEuphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.accessdata.fda.gov
July 13, 201777976Class IITerminatedEuphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.Stylette removal difficulties on the Euphora and Solarice products.accessdata.fda.gov
August 6, 200953012Not yet classifiedTerminatedEndeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland,The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use.accessdata.fda.gov

Compare with other makers

Updated October 9, 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.