FDA 510(k)

Selectra 3D 外导引导管

K号: K193474 · 2020-10-16

决定日期2020-10-16

产品代码DQY

咨询委员会CV

决定Substantially Equivalent

器械摘要

Selectra 3D Outer Guiding Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K193474. 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 3D Outer Guiding Catheters?

Selectra 3D Outer Guiding Catheters is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Biotronik, Inc.. The 510(k) number is K193474.

When did Selectra 3D Outer Guiding Catheters receive FDA 510(k) clearance?

Selectra 3D Outer Guiding Catheters received FDA 510(k) clearance on 2020-10-16, under 510(k) number K193474.

Who is the listed applicant for Selectra 3D Outer Guiding Catheters?

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 3D Outer Guiding Catheters?

The FDA product code for Selectra 3D Outer Guiding Catheters 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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官方来源

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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。