FDA 510(k) Applications Submitted by Medtronic
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191851 |
07/10/2019 |
VS3-IR |
Medtronic |
| K183453 |
12/13/2018 |
VS3-IR |
Medtronic |
| K070286 |
01/29/2007 |
BIO-CONSOLE, MODEL 560 |
Medtronic |
| K171253 |
04/28/2017 |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead |
Medtronic |
| K161249 |
05/03/2016 |
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead |
Medtronic |
| K211596 |
05/24/2021 |
CD Horizon Spinal System |
Medtronic |
| K101864 |
07/02/2010 |
KYPHON XPANDER II INFLATABLE BONE TAMP |
Medtronic |
| K123771 |
12/07/2012 |
KYPHON EXPRESS II INFLATABLE BONE TAMPS |
Medtronic |
| K190716 |
03/19/2019 |
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead |
Medtronic |
| K221244 |
05/02/2022 |
CD HorizonÖ Spinal System |
Medtronic |
| K203111 |
10/15/2020 |
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System |
Medtronic |
| K182610 |
09/21/2018 |
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device |
Medtronic |
| K151227 |
05/07/2015 |
KYPHON XPEDE Bone Cement |
MEDTRONIC |
| K171938 |
06/28/2017 |
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set |
Medtronic |
| K223494 |
11/21/2022 |
CD Horizon Spinal System |
Medtronic |
| K102397 |
08/24/2010 |
KYPHON XPEDE BONE CEMENT |
Medtronic |
| K190132 |
01/28/2019 |
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
Medtronic |
| K183547 |
12/20/2018 |
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter |
Medtronic |
| K132623 |
08/22/2013 |
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE |
Medtronic |
| K090721 |
03/18/2009 |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 |
Medtronic |
| K200514 |
03/02/2020 |
Cardioblate Gemini-s Surgical Ablation Device |
Medtronic |
| K190623 |
03/11/2019 |
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device |
Medtronic |
| K202771 |
09/21/2020 |
CD Horizon Spinal System |
Medtronic |
| K222873 |
09/22/2022 |
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system |
Medtronic |
| K223178 |
10/11/2022 |
SelectSite C304 Deflectable Catheter System, C315 Delivery System |
Medtronic |
| K210449 |
02/16/2021 |
InfinityÖ OCT System, PASS OCT« Spinal System |
Medtronic |
| K210637 |
03/03/2021 |
CD HorizonÖ Spinal System |
Medtronic |
| K201362 |
05/22/2020 |
CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement |
Medtronic |
| K181132 |
04/30/2018 |
Tri-Ad 2.0 Adams Tricuspid Band |
Medtronic |
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