FDA 510(k) Applications Submitted by Medtronic Inc
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K242705 |
09/09/2024 |
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 T |
Medtronic Inc |
| K250199 |
01/23/2025 |
VitalFlow Console |
Medtronic Inc |
| K191077 |
04/23/2019 |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor |
Medtronic Inc |
| K250075 |
01/10/2025 |
Medtronic Stedi Extra Support Guidewire |
Medtronic Inc |
| K180453 |
02/20/2018 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic Inc |
| K160983 |
04/07/2016 |
Kyphon HV-R Bone Cement |
MEDTRONIC INC |
| K192712 |
09/27/2019 |
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter |
Medtronic Inc |
| K183511 |
12/18/2018 |
Affinity PixieÖ Oxygenator with BalanceÖ Biosurface (Model BBP211), Affinity PixieÖ Oxygenator and Cardiotomy/Venous Reservoir with BalanceÖ Biosurface (Model BBP241), Affinity PixieÖ Oxygenator with CortivaÖ BioActive Surface (Model CBP211), Affinity Pix |
Medtronic Inc |
| K183490 |
12/17/2018 |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface |
Medtronic Inc |
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