FDA 510(k)

Deklene MAXX

K号: K193530 · 2020-03-19

决定日期2020-03-19

产品代码GAW

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Deklene MAXX is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K193530. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Deklene MAXX?

Deklene MAXX is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Teleflex Medical. The 510(k) number is K193530.

When did Deklene MAXX receive FDA 510(k) clearance?

Deklene MAXX received FDA 510(k) clearance on 2020-03-19, under 510(k) number K193530.

Who is the listed applicant for Deklene MAXX?

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 Deklene MAXX?

The FDA product code for Deklene MAXX is GAW.

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 →

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。