Medtronic - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
FDA 510(k) cleared devices by Medtronic Cardiovascular ✕
18 devices
Cleared
Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
Cardiovascular
224d
Cleared
Aug 07, 2024
Sphere-9Dx Diagnostic Catheter (AFR-00009)
Cardiovascular
300d
Cleared
Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
Cardiovascular
30d
Cleared
Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
Cardiovascular
28d
Cleared
Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve...
Cardiovascular
46d
Cleared
Sep 16, 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Cardiovascular
336d
Cleared
Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
Cardiovascular
93d
Cleared
Aug 08, 2019
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
Cardiovascular
142d
Cleared
Jul 30, 2019
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...
Cardiovascular
222d
Cleared
Jul 30, 2019
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
Cardiovascular
183d
Cleared
May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...
Cardiovascular
80d
Cleared
Dec 19, 2018
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation...
Cardiovascular
89d
Cleared
May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
Cardiovascular
29d
Cleared
May 25, 2017
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
Cardiovascular
27d
Cleared
Aug 19, 2016
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
Cardiovascular
108d
Cleared
Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
Cardiovascular
119d
Cleared
Jun 16, 2009
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL...
Cardiovascular
90d
Cleared
May 22, 2007
BIO-CONSOLE, MODEL 560
Cardiovascular
113d