MEDTRONIC, INC.

FDA Device Registration & Listing · Mounds View, MN, US · Registration 2182208

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
2182208
FEI Number
2182208
Entity Name
MEDTRONIC, INC.
City/State/Country
Mounds View, MN, US
Establishment Address
8200 Coral Sea Street NE, Mounds View, MN 55112, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K951347
PMA Number
N/A

All Registered Proprietary Names

Marinr Steerable Intracardiac Electrode Catheter StableMapr Steerable Intracardiac Electrode Catheter Reveal LINQ Mobile Manager Application Medtronic Temporary External Pacemaker TYRX Absorbable Antibacterial Envelope PROGRAM STIMULATOR PulseSelect™ Pulsed Field Ablation (PFA) CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025 Epsila EV™ MRI SureScan™ extravascular lead Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator Epsila EV™ Sternal Tunneling Tool AURORA EV-ICD™ MRI SURESCAN™ SW041 Epsila EV™ Transverse Tunneling Tool Pulse Select Sphere 360 Achieve Advance Mapping Catheter and Catheter Connecting Cable 10-Lead 2ACHC FlexCath Advance SELECTSITE™ C304-HIS Deflectable catheter system Impedance Localization Patch Kit TYRX™ Absorbable Antibacterial Envelope Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM Vitatron C20 SR IPG TYRX Absorbable Antibacterial Envelope Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS Surgical Cable Disposable Patient Safety Cable PROGRAM STIMULATOR PLI Kit Reveal LINQ Paceart Optima and Mainspring Data Express Version 6 Discovery Link MDDS N'Vision Report Link Paceart System Get Connected III, Connected Systems Gateway Paceart Optima Clinic Management Component Medtronic CareLink Website DiscoveryLink MDDS Session Management MyCareLink Smart Application iOS CareLink SmartSync Host Application MyCareLink Smart Application Android CareLink Mobile Application Paceart Optima Data Transformation Engine Component CareLink SmartSync Platform iOS CareLink SmartSync Platform Android Patient Connector Patient Data Service App for Intellis Communicator Reveal DX Reveal XT MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter Adjustable Valve StableMapr Reveal LINQ™ Insertion Tools REVEAL LINQ MyCareLink Patient Monitor Model 24950 Patient Assistant Attain Ability Lead Attain Performa MRI SureScan Lead Attain Performa S MRI SureScan Lead Attain Performa S Lead Attain Ability MRI SureScan Lead Attain Ability Straight Lead Attain Performa Straight MRI SureScan Lead Attain Ability Straight MRI SureScan Lead Attain Performa Straight Lead Attain Ability Plus Lead Attain Performa Lead Attain Ability Plus MRI SureScan Lead Attain Stability Quad MRI SureScan Lead AccuRhythm AI (Zelda AI) Paceart Optima System 1.6 with Analytics Paceart Optima Paceart Optima System 1.7 Paceart Optima System 1.8 Attain 6227DEF Patient Assistant Torqr Intracardiac Electrode Catheter Soloist Intracardiac Electrode Catheter Percutaneous Lead Introducers TYRX™ Neuro Absorbable Antibacterial Envelope Percutaneous Lead Introducer Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) FlexCath Cross™ Transseptal Solution SELECTSITE™ FlexCath Advance Steerable Sheath and Dilator ATAKR Accessory RF ENHANCR II RF CONTACTR Cable RF MARINR RF CONDUCTR CareLink Network Software Protecta VR Protecta XT CRT-D Marquis VR ICD Visia AF MRI VR SureScan Evera XT VR Protecta DR Visia AF MRI S VR SureScan Virtuoso II DR/VR ICD Maximo II DR Visia AF VR Evera MRI S VR Evera XT DR Evera MRI XT DR SureScan Maximo VR ICD Evera S DR Evera MRI S DR SureScan Marquis DR ICD Evera S VR Secura DR Protecta XT VR Protecta XT DR Intrinsic ICD Evera MRI XT VR SureScan EnTrust ICD Secura VR Evera Medtronic Longevity Maximo II VR Maximo DR ICD Primo MRI VR SureScan Primo MRI DR SureScan Cobalt XT DR MRI Surescan Cobalt VR MRI Surescan Cobalt DR MRI Surescan Crome DR MRI Surescan Crome VR MRI Surescan Cobalt XT VR MRI Surescan 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 CareLink SmartSync Patient Connector 24967 PCD End Cap GEM Patient Cable Lead Patch MICRO JEWEL Patient Magnet MICRO JEWEL II Ace Header Emulator Epicardial Patch Lead Upsizing Sleeve Sizing Sleeve GEM VR FlexCath Cross™ Transseptal Solution Capsure SP Novus Vitatron Crystalline Lead CapSure Sense Adhesive Vitatron Excellence PS+ Lead stylet kit CapSure Unipolar Lead CapSure Sense MRI SureScan Leads Attain Command + SureValve Left-Heart Delivery System Attain Select II + SureValve Delivery Catheter System Attain Command + SureValve Guide Catheter for Left-Heart Delivery Affera™ Integrated Mapping System Achieve TORQR Cables 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 SOLOIST Patient Magnet CareLink SmartSync Power Supply 249701 CareLink SmartSync Common Application Android CareLink SmartSync Power Cord 249705 CareLink SmartSync PSA Application CareLink SmartSync Base 24970A CareLink SmartSync Common Application iOS Adaptor Disposable Pouch Patient Cable Disposable EPG Cover OmniaSecure™ MRI SureScan™ ECVUE Cardiac Mapping System Surgical cable Lead Adaptor Kit FlexCath Contour™ Steerable Sheath External Pacemaker Pulse Generator Reveal LINQ Mobile Manager patient connector Reveal XT Reveal XT Patient Assistant LINQ II™ Insertable Cardiac Monitor (ICM) Attain Prevail 6228 CTH Cosine-10 Diagnostic Catheter TORQR Magnetic localization Patch Kit Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Protecta XT CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan CareLink SmartSync Common Application iOS CareLink SmartSync Azure Astra Application LINQ II™ Insertable Cardiac Monitor (LNQ22) Freezor MAX External Pulse Generator EPG Cover Paceart Percutaneous lead introducer LINQ Tool Kit LINQ II Insertable Cardiac Monitor External Pulse Generator PROGRAM STIMULATOR SEEQ Mobile Cardiac Telemetry (MCT) System NUVANT Mobile Cardiac Telemetry (MCT) System SEEQ External Cardiac Monitor (ECM) System CapSureFix Lead CapSureFix Novus MRI SureScan Leads Vitatron Crystalline Lead SureFix CapSureFix Novus Leads Lead Adaptor HeartWare Ventricular Assist System External Pulse Generator LINQ II Insertable Cardiac Monitor Achieve Advance Mapping Catheter Micra Introducer Sheath with Hydrophilic Coating Epicardial Lead Implant Tool PROGRAM STIMULATOR C320LBB Delivery System MARINR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-07-09
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2016-05-26
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2018-09-07
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-06-13
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Cardiovascular Class 2 870.1750 1992-12-02
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2023-12-15
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2023-10-23
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2023-10-23
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2026-02-24
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-08
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2019-02-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-04-03
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-02-11
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2021-01-11
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2013-03-28
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2007-11-29
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2007-11-29
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2007-11-29
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2007-11-29
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-10-10
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
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2008-09-16
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Cardiovascular Class 2 870.1750 1992-12-02
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-02-21
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2021-07-22
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-05-03
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2007-11-29
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 1992-12-02
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2005-10-27
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2010-08-10
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2014-02-18
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2018-04-02
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2015-05-29
OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown Class 3 N/A 2010-08-04
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2021-12-13
KRE Analyzer, Pacemaker Generator Function, Indirect Cardiovascular Class 2 870.3640 2011-06-14
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-06-14
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2011-06-14
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2011-06-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-16
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-06-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2020-07-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-12
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2021-04-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-12
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2007-01-24
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2007-01-24
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2007-01-24
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2007-01-24
KRG Programmer, Pacemaker Cardiovascular Class 3 870.3700 2007-01-24
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2007-01-24
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-04-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-04-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-06-26
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2020-12-18
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2007-12-12
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2002-05-02
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2002-05-02
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2002-05-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-10-14
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2017-05-15
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2009-06-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-04-23
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-04-23
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2008-03-12
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2008-03-12
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2008-03-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-04-11
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-02-11
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-03-17
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2011-12-15
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2021-06-09
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2011-12-15
DTG Magnet, Test, Pacemaker Cardiovascular Class 1 870.3690 2021-11-09
DTC Analyzer, Pacemaker Generator Function Cardiovascular Class 2 870.3630 2017-05-15
DTA Tester, Pacemaker Electrode Function Cardiovascular Class 2 870.3720 2017-05-15
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2009-06-09
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2009-05-21
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2025-05-28
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2016-02-04
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2015-03-05
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2011-01-24
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2023-11-27
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2013-12-05
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2015-09-03
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2007-11-27
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2024-04-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-16
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-12-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2011-12-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-02-11
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2002-11-22
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2002-11-22
KRG Programmer, Pacemaker Cardiovascular Class 3 870.3700 2002-11-22
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2002-11-22
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2002-11-22
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2002-11-22
DTA Tester, Pacemaker Electrode Function Cardiovascular Class 2 870.3720 2018-06-15
OUG Medical Device Data System General Hospital Class 1 880.6310 2023-11-07
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2023-11-07
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2023-11-07
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2015-09-25
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2019-07-03
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2008-07-28
KRE Analyzer, Pacemaker Generator Function, Indirect Cardiovascular Class 2 870.3640 2008-07-28
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2008-07-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-04-25
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2020-07-08
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2017-01-19
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Cardiovascular Class 2 870.1750 1992-12-02
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2014-08-27
QYX Outpatient Cardiac Telemetry Cardiovascular Class 2 870.1025 2014-08-27
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2007-12-06
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2007-12-06
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2007-12-06
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2011-01-24
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2016-09-14
DTE Pulse-Generator, Pacemaker, External Cardiovascular Class 2 870.3600 2018-09-13
MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) Cardiovascular Class 2 870.1025 2021-06-04
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2016-12-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-11-15
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2015-03-12
JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) Cardiovascular Class 2 870.1750 1992-12-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-01-08
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2011-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K881966 C.R. Bard, Inc. ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER 1988-10-04
K192037 ABBOTT MEDICAL Advisor VL Circular Mapping Catheter, Sensor Enabled 2019-09-17
K253516 ABBOTT MEDICAL Assert-IQ (DM5100) 2025-12-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2016 Medtronic Inc. Cardiac Rhythm Disease Management 3
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Z-0002-2007 Guidant Corporation 3
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Z-0003-2018 St Jude Medical Inc. 3
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
Z-0037-2012 Boston Scientific CRM Corp 3
LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
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.

Similar Registrations

Registration Number Establishment Name Location
3010273872 Synergy Health AST, SRL Alajuela, CR
3012179728 St. Jude Medical Roseville, MN, US
1319639 Sterigenics U.S., LLC Queensbury, NY, US
1721686 Sterigenics U.S., LLC Santa Teresa, NM, US
3005402529 ACCESS POINT TECHNOLOGIES, EP INC. Rogers, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182208. Last updated year: 2026. Please use registration number 2182208 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.