FDA 510(k)

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

K号: K221840 · 2022-10-14

申请人Integra Lifesciences Production Corporation

决定日期2022-10-14

产品代码JXG

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决定实质等同

器械摘要

Hakim Programmable Valves, Hakim Precision Fixed Pressure 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 2022-10-14 under 510(k) number K221840. 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 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves?

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K221840.

When did Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves receive FDA 510(k) clearance?

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221840.

Who is the listed applicant for Hakim Programmable Valves, Hakim Precision Fixed Pressure 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 Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves?

The FDA product code for Hakim Programmable Valves, Hakim Precision Fixed Pressure 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

查看所有 9 个设备 →

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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