FDA 510(k) Applications Submitted by MEDTRONIC, INC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150246 |
02/02/2015 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc |
| K142673 |
09/19/2014 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic, Inc |
| K143083 |
10/27/2014 |
Bio-Medicus Pediatric Cannula and Introducers |
MEDTRONIC, INC |
| K151110 |
04/27/2015 |
Intersept Filtered Cardiotomy Reservoir |
Medtronic, Inc |
| K190574 |
03/06/2019 |
Patient Assistant Model PA97000 |
Medtronic, Inc |
| K212027 |
06/29/2021 |
TurboHawk Plus Directional Atherectomy System |
Medtronic, Inc |
| K142784 |
09/26/2014 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface |
Medtronic, Inc |
| K150530 |
03/02/2015 |
Level Sensor, Level Sensor Tape |
Medtronic, Inc |
| K251258 |
04/23/2025 |
MC2Ö Two-Stage Venous Cannula; MC2XÖ Three-Stage Venous Cannula |
Medtronic, Inc |
| K233838 |
12/04/2023 |
Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); CovidienÖ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneo |
Medtronic, Inc |
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