BIOMONITOR IV（471155）
K号: K261074 · 2026-05-01
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器械摘要
BIOMONITOR IV (471155) is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K261074. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BIOMONITOR IV (471155)?
BIOMONITOR IV (471155) is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Biotronik, Inc.. The 510(k) number is K261074.
When did BIOMONITOR IV (471155) receive FDA 510(k) clearance?
BIOMONITOR IV (471155) received FDA 510(k) clearance on 2026-05-01, under 510(k) number K261074.
Who is the listed applicant for BIOMONITOR IV (471155)?
The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIOMONITOR IV (471155)?
The FDA product code for BIOMONITOR IV (471155) is MXD.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Biotronik, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K250706Passeo-35 Xeo 周围血管扩张导管；Passeo-18 周围血管扩张导管；Passeo-14 周围血管扩张导管；Oscar 多功能导管系统；Pantera Pro 经皮腔内冠状动脉成形术导管；Pantera LEO 经皮腔内冠状动脉成形术（PTCA）导管K242969Pantera Pro; Pantera LEOK240787Selectra 3D 导线递送系统（443624-443629，451789-451791）；Selectra 切割工具（383119）；Selectra 配件套件（375518）K241711Oscar 外周多功能导管系统K230375BIOMONITOR IVK222065Passeo-35 Xeo周围扩张导管
相关器械（代码：MXD）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICALK251221Assert-IQ (DM5000)；Assert-IQ (DM5300)；Assert-IQ (DM5500)；Merlin.net (MN7000)AbbottK252593LUX-Dx II 可植入式心脏监测器 (M302); LUX-Dx II+ 可植入式心脏监测器 (M312)Boston Scientific CorporationK240693LINQ II®植入式心脏监测器（ICM）Medtronic, Inc.K233562LINQ II 可植入式心脏监测器Medtronic, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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