FDA 510(k)

Selectra 导线植入系统

K号: K222037 · 2022-07-19

决定日期2022-07-19

产品代码DQY

咨询委员会CV

决定Substantially Equivalent

器械摘要

Selectra Lead Implantation System is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-19 under 510(k) number K222037. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Selectra Lead Implantation System?

Selectra Lead Implantation System is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Biotronik, Inc.. The 510(k) number is K222037.

When did Selectra Lead Implantation System receive FDA 510(k) clearance?

Selectra Lead Implantation System received FDA 510(k) clearance on 2022-07-19, under 510(k) number K222037.

Who is the listed applicant for Selectra Lead Implantation System?

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 Selectra Lead Implantation System?

The FDA product code for Selectra Lead Implantation System is DQY.

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 K242969Pantera Pro; Pantera LEO 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 IV

查看所有 23 个设备 →

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。