Pantera Pro; Pantera LEO
K号: K242969 · 2024-10-25
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器械摘要
Pantera Pro; Pantera LEO is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242969. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pantera Pro; Pantera LEO?
Pantera Pro; Pantera LEO is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Biotronik, Inc.. The 510(k) number is K242969.
When did Pantera Pro; Pantera LEO receive FDA 510(k) clearance?
Pantera Pro; Pantera LEO received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242969.
Who is the listed applicant for Pantera Pro; Pantera LEO?
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 Pantera Pro; Pantera LEO?
The FDA product code for Pantera Pro; Pantera LEO is LOX.
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。
K261074BIOMONITOR IV（471155）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K240787Selectra 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：LOX）
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。
K261428NC Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic IrelandK261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic IrelandK252116Firefighter™ Pro PTCA 气囊导管Shanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex® 主动脉-开口血管成形术系统Verge Medical, Inc.K252295RyureiTerumo CorporationK251970Sprinter传奇快速交换球囊扩张导管Medtronic, Ireland
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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