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Biotronik, Inc.

FDA 510(k) & PMA Approved 器材 — 23 products

器材總數23
類別0
最新 FDA 裁決
類型編號器材名稱代碼日期操作
510(k) K261074 BIOMONITOR IV (471155)MXD2026-05-01 查看
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) CatheterLIT2025-04-04 查看
510(k) K242969 Pantera Pro; Pantera LEOLOX2024-10-25 查看
510(k) K240787 Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)DQY2024-09-12 查看
510(k) K241711 Oscar Peripheral Multifunctional Catheter systemLIT2024-07-11 查看
510(k) K230375 BIOMONITOR IVMXD2023-05-19 查看
510(k) K222065 Passeo-35 Xeo Peripheral Dilatation CatheterLIT2023-02-16 查看
510(k) K221856 BIOMONITOR IIIm, BIOMONITOR IIIMXD2022-07-27 查看
510(k) K222037 Selectra Lead Implantation SystemDQY2022-07-19 查看
510(k) K214038 Oscar Peripheral Multifunctional Catheter systemLIT2022-07-06 查看
510(k) K201445 MultiCath, AcQRate Dx Fixed Curve CatheterDRF2021-09-02 查看
510(k) K201865 Biomonitor III, Biomonitor IIImMXD2020-12-08 查看
510(k) K193474 Selectra 3D Outer Guiding CathetersDQY2020-10-16 查看
510(k) K200444 Biomonitor III, Biomonitor IIImMXD2020-04-23 查看
510(k) K192996 Selectra Catheters, Selectra Accessory Kit, Selectra Slitter ToolDQY2019-11-21 查看
510(k) K191469 Biotronik StyletsDRB2019-08-01 查看
510(k) K190548 BIOMONITOR III, Remote Assistant IIIMXD2019-07-05 查看
510(k) K183265 Selectra Catheters, Selectra Accessory KitDQY2018-12-13 查看
510(k) K171514 BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, SetMXD2017-06-29 查看
510(k) K170628 BioMonitor 2-AF, BioMonitor 2-SMXD2017-03-31 查看
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