FDA 510(k)

Sheridan 内支气管管

K号: K180253 · 2018-11-02

决定日期2018-11-02

产品代码CBI

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Sheridan Endobronchial Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K180253. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sheridan Endobronchial Tubes?

Sheridan Endobronchial Tubes is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Teleflex Medical. The 510(k) number is K180253.

When did Sheridan Endobronchial Tubes receive FDA 510(k) clearance?

Sheridan Endobronchial Tubes received FDA 510(k) clearance on 2018-11-02, under 510(k) number K180253.

Who is the listed applicant for Sheridan Endobronchial Tubes?

FDA 510(k)记录显示Teleflex Medical为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Sheridan Endobronchial Tubes?

The FDA product code for Sheridan Endobronchial Tubes is CBI.

列明Teleflex Medical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。

K261418Liquick X-treme，Liquick X-treme Plus K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips K242495LMA Fastrach ETT SU K243553QuikClot Control+ 止血装置 K241784Arrow® Nitinol Wire K233713Pilling 气管切开管

查看所有 21 个设备 →

相关器械（代码：CBI）

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。

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。