Medical Device Manufacturer · US , Mounds View , MN

Medtronic, Inc.

208 submissions · 207 cleared · Since 1981
208
Total
207
Cleared
0
Denied

Medtronic, Inc. — FDA 510(k) Submissions

Medtronic, Inc. has submitted 208 FDA 510(k) premarket notifications since 1981, of which 207 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection), Oxygenator, Cardiopulmonary Bypass, Catheter, Percutaneous, Pulse-generator, Pacemaker, External . Use the specialty filter in the sidebar to narrow results.

208 devices
1–25 of 208
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF Catheter, Cannula And... · Cardiovascular
Feb 2026 146d
Clearview Intracoronary Shunts
K253998 · DWF Catheter, Cannula And... · Cardiovascular
Jan 2026 39d
Bio-Medicus Life Support Catheter and Introducer
K251831 · QHW Single Lumen Ecmo Cannula · Cardiovascular
Jan 2026 216d
Concerto Versa? Detachable Coil
K253511 · KRD Device, Vascular, For... · Cardiovascular
Jan 2026 70d
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · DQY Catheter, Percutaneous · Cardiovascular
Dec 2025 80d
MC2? Two-Stage Venous Cannula; MC2X? Three-Stage Venous Cannula
K251258 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2025 58d
Medtronic Stedi Extra Support Guidewire
K250075 · DQX Wire, Guide, Catheter · Cardiovascular
Jun 2025 154d
VitalFlow Console
K250199 · QNR Blood Pump For Ecmo,... · Cardiovascular
May 2025 117d
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
K250558 · DQY Catheter, Percutaneous · Cardiovascular
Mar 2025 30d
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
K242705 · LDF Electrode, Pacemaker,... · Cardiovascular
Jan 2025 130d
Affera Integrated Mapping System
K243892 · DQK Computer, Diagnostic,... · Cardiovascular
Jan 2025 30d
Magnetic Localization Patch Kit (AFR-00021)
K243435 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2024 30d
Affera Integrated Mapping System; Impedance Localization Patch Kit
K241828 · DQK Computer, Diagnostic,... · Cardiovascular
Nov 2024 130d
VitalFlow Set with Balance Biosurface
K240880 · QJZ Extracorporeal System For... · Cardiovascular
Sep 2024 164d
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
K241352 · DTZ Oxygenator,... · Cardiovascular
Jun 2024 30d
Amplatz Goose Neck Snare Kit
K241259 · MMX Device, Percutaneous... · Cardiovascular
Jun 2024 28d
Bio-Medicus Life Support Catheter and Introducer
K240534 · QHW Single Lumen Ecmo Cannula · Cardiovascular
Apr 2024 53d
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien? Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien? Remote Temperature Probe (RTP20); Covidien? Remote Temperature Probe, Bulk (RTP20B)
K233838 · NEY System, Ablation,... · General & Plastic Surgery
Mar 2024 115d
LINQ II? Insertable Cardiac Monitor (ICM)
K240693 · MXD Recorder, Event,... · Cardiovascular
Mar 2024 15d
Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
K233943 · DQK Computer, Diagnostic,... · Cardiovascular
Mar 2024 85d
DLP Silicone Coronary Artery Ostial Cannulae
K231206 · DWF Catheter, Cannula And... · Cardiovascular
Dec 2023 224d
LINQ II Insertable Cardiac Monitor
K233562 · MXD Recorder, Event,... · Cardiovascular
Dec 2023 30d
Cosine-10TM Diagnostic Catheter
K233397 · DRF Catheter, Electrode... · Cardiovascular
Dec 2023 60d
FlexCath Contour? Steerable Sheath
K232321 · DRA Catheter, Steerable · Cardiovascular
Oct 2023 89d
LINQ II? Insertable Cardiac Monitor (LNQ22)
K233320 · MXD Recorder, Event,... · Cardiovascular
Oct 2023 32d

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