FDA 510(k)

Selectra 导尿管，Selectra 配件套件

K号: K183265 · 2018-12-13

决定日期2018-12-13

产品代码DQY

咨询委员会CV

决定Substantially Equivalent

器械摘要

Selectra Catheters, Selectra Accessory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K183265. 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 Catheters, Selectra Accessory Kit?

Selectra Catheters, Selectra Accessory Kit is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Biotronik, Inc.. The 510(k) number is K183265.

When did Selectra Catheters, Selectra Accessory Kit receive FDA 510(k) clearance?

Selectra Catheters, Selectra Accessory Kit received FDA 510(k) clearance on 2018-12-13, under 510(k) number K183265.

Who is the listed applicant for Selectra Catheters, Selectra Accessory Kit?

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 Catheters, Selectra Accessory Kit?

The FDA product code for Selectra Catheters, Selectra Accessory Kit 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

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