Biotronik, Inc.
FDA 510(k) & PMA Approved Devices — 79 products
Total Devices79
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261074 | BIOMONITOR IV (471155) | MXD | 2026-05-01 | View |
| 510(k) | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | LIT | 2025-04-04 | View |
| 510(k) | K242969 | Pantera Pro; Pantera LEO | LOX | 2024-10-25 | View |
| 510(k) | K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518) | DQY | 2024-09-12 | View |
| 510(k) | K241711 | Oscar Peripheral Multifunctional Catheter system | LIT | 2024-07-11 | View |
| 510(k) | K230375 | BIOMONITOR IV | MXD | 2023-05-19 | View |
| 510(k) | K222065 | Passeo-35 Xeo Peripheral Dilatation Catheter | LIT | 2023-02-16 | View |
| 510(k) | K221856 | BIOMONITOR IIIm, BIOMONITOR III | MXD | 2022-07-27 | View |
| 510(k) | K222037 | Selectra Lead Implantation System | DQY | 2022-07-19 | View |
| 510(k) | K214038 | Oscar Peripheral Multifunctional Catheter system | LIT | 2022-07-06 | View |
| 510(k) | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | DRF | 2021-09-02 | View |
| 510(k) | K201865 | Biomonitor III, Biomonitor IIIm | MXD | 2020-12-08 | View |
| 510(k) | K193474 | Selectra 3D Outer Guiding Catheters | DQY | 2020-10-16 | View |
| 510(k) | K200444 | Biomonitor III, Biomonitor IIIm | MXD | 2020-04-23 | View |
| 510(k) | K192996 | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool | DQY | 2019-11-21 | View |
| 510(k) | K191469 | Biotronik Stylets | DRB | 2019-08-01 | View |
| 510(k) | K190548 | BIOMONITOR III, Remote Assistant III | MXD | 2019-07-05 | View |
| 510(k) | K183265 | Selectra Catheters, Selectra Accessory Kit | DQY | 2018-12-13 | View |
| 510(k) | K171514 | BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set | MXD | 2017-06-29 | View |
| 510(k) | K170628 | BioMonitor 2-AF, BioMonitor 2-S | MXD | 2017-03-31 | View |
No matching devices.