Medtronic - FDA 510(k) Cleared Devices
Recent clearances: DLP PVC Left Heart Vent, Trexon™ Monofilament Synthetic Absorbable Suture, Affinity Pixie™ Arterial Filter with Balance™ Biosurface
34
Total
34
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Cardiovascular ✕
19 devices
Cleared
Oct 23, 2026
DLP PVC Left Heart Vent
Cardiovascular
147d
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
CT
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