Medtronic, Inc.

FDA Device Registration & Listing · Plymouth, MN, US · Registration 2183870

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
2183870
FEI Number
2183870
Entity Name
Medtronic, Inc.
City/State/Country
Plymouth, MN, US
Establishment Address
4600 Nathan Lane North, Plymouth, MN 55442, 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
K192966
PMA Number
N/A

All Registered Proprietary Names

Enteer (Mantaray) Guidewire M-600,M6001,M6002,M-6003,M-6004,M-6005 Fortrex HP PTA Balloon Catheter NanoCross Elite 14 Over The Wire PTA Balloon Dilatation Catheter NanoCross Elite™ PTA Catheter TrailBlazer™ Angled Support Catheter Rinspirator Enteer (Mantaray) Percutaneous Catheter M-4000 and M-4001 HawkOne Directional Atherectomy System HawkOne 7Fr ClosureFast™ Endovenous Radiofrequency Ablation Catheter PowerCross 18 OTW Balloon Cable Sets MVP Detachment System Micro Vascular Plug System Detachment System (MVP) Micro Vascular Plug System (MVP) Cable Sets MVP SilverHawk for Surgical Use TurboHawk Supper Cutter LS-E, LX-E ClosureFAST™ Endovenous Radiofrequency Ablation (RFA) Catheter Amphirion Deep 014" OTW PTA Balloon Catheter Amphirion Deep PTA Catheter Amphirion Deep PTA Catheter Amphirion Deep 014" OTW PTA Balloon Catheter (Balloon Extension) Amphirion Deep 014” OTW PTA Balloon Catheter Wholey Guide Wire System Wholey Wire Abre™ Venous Self-expanding Stent System Protege GPS Self-Expanding Peripheral Stent System Protege EverFlex PRP35 Orion Micro Catheter ClosureRFS™ Endovenous Radiofrequency Stylet EverCross™ PTA Catheter SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Protege GPS Self-Expanding Peripheral Stent System Protege EverFlex self-expanding biliary stent system Everflex Self-Expanding Peripheral Stent With Entrust Delivery System Protege EverFlex Self-Expanding Peripheral Stent System EverFlex Self-Expanding Peripheral Stent System Protege EverFlex Amplatz™ Goose Neck Snare Kit PRIMUS GPS Biliary Stent (Visi-Pro) Amplatz Goose Neck Microsnare AqWire Hydrophilic Guidewire TurboHawk Peripheral Plaque Excision System BTK (models SS-C, SS-CL, SX-C) Regulation Name: Intraluminal Artery Strippe Mantaray Guidewire Enteer™ Guidewire SilverHawk Peripheral Plaque Excisi VNUS Radiofrequency Generator, Model RFG2 ClosureRFG Radiofrequency Generator (RFG2) RFG2 Next Gen RFG2 ClosureRFG™ Radiofrequency Generator ClosureFAST™ Endovenous Radiofrequency Ablation (RFA) Catheter ClosureFAST™ Radiofrequency Ablation Catheter Micro Vascular Plug System (MVP) SilverHawk Peripheral Plaque Excision System SpiderFX Embolic Protection Device Peripheral Indication Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon) Nitrex Guidewire IntraStent Mega/Max LD Stent, Bilia Chocolate PTA Balloon Catheter NanoCross 14 OTW PTA SpiderFX Embolic Protection Device TrailBlazer™ Support Catheter PROTEGE GPS AND PROTEGE PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS The Big Easy Y-Adapter models SS-C, SS-CL, SX-C TurboHawk Peripheral Plaque Excision System models THS-LS-C, THS-LX-C TurboHawk Peripheral Plaque Excision System EverCross™ PTA Catheter VenaSeal™ Closure System Pacific Plus PTA Catheter "Micro Vascular Plug System (MVP) MVP Cable Sets MVP Detachment System " Amplatz Goose Neck Snare Kit/Catheter SilverHawk Peripheral Plaque Excision System EverCross™ PTA Catheter Peripheral System Percutaneous Catheter Mantaray Catheters Mantaray Guidewires BigBoss Catheters Enteer Re-entry Catheter, Enteer GuideWire, Viance Crossing Catheter RapidCross PTA Rapid Exchange Balloon Dilatation Catheter RapidCross RX PTA Catheter TurboHawk Plus Directional Atherectomy System BridgePoint Medical Peripheral System: Mantaray™ Guidewires Mantaray™ Guidewires Enteer Guidewire Protege EverFlex Self-Expanding Biliary Stent System Protege EverFlex Biliary 6-8mm Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme Protege EverFlex Self-Expanding Biliary Stent System Pacific Plus PTA Catheter Chocolate PTA Balloon Catheter NanoCross Elite™ PTA Catheter HawkOne™ Directional Atherectomy System Intraluminal artery stripper HawkOne Directional Atherectomy System HawkOne 6Fr Admiral Xtreme PTA Balloon Dilatation Catheter Admiral Xtreme PTA Balloon Catheter Protege GPS self-expanding peripheral stent system Amphirion Deep 014" OTW PTA Balloon Catheter (Long Balloon) Amphirion Deep 014” OTW PTA Balloon Catheter Amphirion Deep PTA Catheter FlowMet-D

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-11-28
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-11-13
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-12-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-10-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2008-07-14
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2008-07-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-21
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-11-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2009-12-03
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2009-12-03
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2016-08-22
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2008-07-14
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2009-12-03
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-08-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-04-30
QAN Stent, Iliac Vein Unknown Class 3 N/A 2020-10-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-10-21
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2020-09-04
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-07-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-08-18
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-04-26
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-04-26
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-15
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-05-29
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2012-04-30
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2024-08-26
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2024-08-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-10-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-07
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-11-28
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2008-07-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-08-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-08-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-08-18
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2020-08-18
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-11-13
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2011-11-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-10-09
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-10-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-24
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-10-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2018-03-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2009-02-03
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection Cardiovascular Class 2 870.1250 2008-10-21
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2009-09-02
NIO Stent, Iliac Unknown Class 3 N/A 2007-02-08
NIM Stent, Carotid Unknown Class 3 N/A 2007-02-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2010-08-25
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2011-01-17
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2012-01-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2010-12-21
PJQ Agent, Occluding, Vascular, Permanent Unknown Class 3 N/A 2017-12-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2020-11-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2016-08-22
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2008-10-21
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-11-13
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-04-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-04-29
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2012-11-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-12-10
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2021-09-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-11-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-06-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-08-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-08-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-02-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-02-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2021-12-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-12-23
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2016-03-18
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2016-10-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2018-04-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-09-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-05-26
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2020-03-27

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
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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 2183870. Last updated year: 2026. Please use registration number 2183870 when referencing this establishment in official correspondence.
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