MEDTRONIC IRELAND

FDA Device Registration & Listing · GALWAY, IE · Registration 9612164

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9612164
FEI Number
3002806434
Entity Name
MEDTRONIC IRELAND
City/State/Country
GALWAY, IE
Establishment Address
PARKMORE BUSINESS PARK WEST, GALWAY --, IE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K061480
PMA Number
N/A

All Registered Proprietary Names

Euphora Rapid Exchange Balloon Dilatation Catheter Harmony Transcatheter Pulmonary Valve System Reliant Stent Graft Balloon Catheter Attain Select II 6248DEL HawkOne™ Directional Atherectomy System Telescope™ Guide Extension Catheter TurboHawk Peripheral Plaque Excision System BTK (models SS-C, SS-CL, SX-C) Regulation Name: Intraluminal Artery Strippe SELECTSITE™ NC Euphora" Rapid Exchange Balloon Dilatation Catheter Attain Select II + SureValve Delivery System Attain Command + SureValve Delivery System Sprinter Legend RX Sprinter Over-the-Wire NC Sprinter RX NC Stormer Over-the-Wire DiamondTemp™ Generator Connection Box E DiamondTemp™ RF Generator DiamondTemp™ EGM Cable DiamondTemp™ GenConnect Cable DiamondTemp™ Irrigation Tubing Set DiamondTemp Ablation System DiamondTemp™ Catheter-to-RF Generator Cable DiamondTemp™ Irrigation Pump DiamondTemp™ Ablation Catheter DiamondTemp™ Foot Switch SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM TurboHawk Plus Directional Atherectomy System Sprinter Legend 1.25 OTW Sprinter Legend 1.25 RX Endurant II AUI Stent Graft System Endurant Stent Graft System Endurant IIs Stent Graft System Endurant II Stent Graft System Talent Occluder with Occluder Delivery System In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter Attain Command + SureValve Left-Heart Delivery System Attain Select II + SureValve Delivery Catheter System Attain Command + SureValve Guide Catheter for Left-Heart Delivery C315 Delivery Catheter SelectSite C304-S59 SelectSite C304-XL74 SelectSite C304-L69 TurboHawk Peripheral Plaque Excision System SilverHawk Peripheral Plaque Excision System Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS SELECTSITE™ C304-HIS Deflectable catheter system HawkOne™ Directional Atherectomy System Heli-FX EndoAnchor System Symplicity Spyral™ Renal Denervation System Attain Command 6250 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Onyx Frontier Zotarolimus-Eluting Coronary Stent System Confida CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System VenaSeal™ Closure System ARES Antibiotic Impregnated Catheters Liberant™ Thrombectomy System Attain Command + SureValve Guide Catheters for Left Heart Delivery Attain Select II + SureValve Delivery Catheter System Attain Command + SureValve Left Heart Delivery System C315 Delivery Catheter FlexCath Contour™ Steerable Sheath Attain 6227DEF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2015-04-07
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2021-04-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-16
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-03-25
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-06-26
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2014-08-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-06-27
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2008-01-16
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2021-06-09
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-15
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2021-09-01
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2010-10-28
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2010-12-22
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2014-12-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-04-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-09-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-16
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-15
PNJ Leadless Pacemaker Cardiovascular Class 3 870.3610 2016-04-07
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2016-04-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-04-03
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-12
OTD Endovascular Suturing System Cardiovascular Class 2 870.3460 2017-06-23
QYI Ablation Catheter, Renal Denervation Unknown Class 3 N/A 2023-11-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2009-07-15
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2017-04-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-08-13
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2014-01-17
PJQ Agent, Occluding, Vascular, Permanent Unknown Class 3 N/A 2017-12-14
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2012-01-01
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2025-06-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-10-14
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2023-11-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Ryan Calabrese Email: ryan.s.calabrese@medtronic.com Phone: (763) 5263515

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612164. Last updated year: 2026. Please use registration number 9612164 when referencing this establishment in official correspondence.
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