FDA 510(k)

Certas Plus 可编程阀门

K号: K223330 · 2023-02-01

申请人Integra Lifesciences Production Corporation

决定日期2023-02-01

产品代码JXG

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决定实质等同

器械摘要

Certas Plus Programmable Valves is the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K223330. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Certas Plus Programmable Valves?

Certas Plus Programmable Valves is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K223330.

When did Certas Plus Programmable Valves receive FDA 510(k) clearance?

Certas Plus Programmable Valves received FDA 510(k) clearance on 2023-02-01, under 510(k) number K223330.

Who is the listed applicant for Certas Plus Programmable Valves?

The FDA 510(k) record lists Integra Lifesciences Production Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Certas Plus Programmable Valves?

The FDA product code for Certas Plus Programmable Valves is JXG.

列明Integra Lifesciences Production Corporation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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）K243531Codman Libertís分流导管，带Bactiseal和Endexo技术 K243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）K232890CereLink ICP 监测仪（826820），CereLink ICP 延长线（826845）K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

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相关器械（代码：JXG）

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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini 单压力阀 (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís分流导管，带Bactiseal和Endexo技术Integra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）Integra Lifesciences Production Corporation

官方来源

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