FDA 510(k) Applications Submitted by Biotronik, Inc
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K170628 |
03/02/2017 |
BioMonitor 2-AF, BioMonitor 2-S |
BIOTRONIK, Inc |
K160985 |
04/08/2016 |
Pantera Pro |
BIOTRONIK, INC |
K201445 |
06/01/2020 |
MultiCath, AcQRate Dx Fixed Curve Catheter |
Biotronik, Inc |
K191469 |
06/03/2019 |
Biotronik Stylets |
Biotronik, Inc |
K192996 |
10/28/2019 |
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
Biotronik, Inc |
K193474 |
12/16/2019 |
Selectra 3D Outer Guiding Catheters |
BIOTRONIK, Inc |
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