Biotronik, Inc.

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

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최신 FDA 결정

유형	번호	기기명	코드	날짜	작업
510(k)	K261074	BIOMONITOR IV (471155)	MXD	2026-05-01	보기
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	보기
510(k)	K242969	Pantera Pro; Pantera LEO	LOX	2024-10-25	보기
510(k)	K240787	Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)	DQY	2024-09-12	보기
510(k)	K241711	Oscar Peripheral Multifunctional Catheter system	LIT	2024-07-11	보기
510(k)	K230375	BIOMONITOR IV	MXD	2023-05-19	보기
510(k)	K222065	Passeo-35 Xeo Peripheral Dilatation Catheter	LIT	2023-02-16	보기
510(k)	K221856	BIOMONITOR IIIm, BIOMONITOR III	MXD	2022-07-27	보기
510(k)	K222037	Selectra Lead Implantation System	DQY	2022-07-19	보기
510(k)	K214038	Oscar Peripheral Multifunctional Catheter system	LIT	2022-07-06	보기
510(k)	K201445	MultiCath, AcQRate Dx Fixed Curve Catheter	DRF	2021-09-02	보기
510(k)	K201865	Biomonitor III, Biomonitor IIIm	MXD	2020-12-08	보기
510(k)	K193474	Selectra 3D Outer Guiding Catheters	DQY	2020-10-16	보기
510(k)	K200444	Biomonitor III, Biomonitor IIIm	MXD	2020-04-23	보기
510(k)	K192996	Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool	DQY	2019-11-21	보기
510(k)	K191469	Biotronik Stylets	DRB	2019-08-01	보기
510(k)	K190548	BIOMONITOR III, Remote Assistant III	MXD	2019-07-05	보기
510(k)	K183265	Selectra Catheters, Selectra Accessory Kit	DQY	2018-12-13	보기
510(k)	K171514	BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set	MXD	2017-06-29	보기
510(k)	K170628	BioMonitor 2-AF, BioMonitor 2-S	MXD	2017-03-31	보기