FDA 510(k)

Cardinal Health NPWT 灌流导管套装，Cardinal Health NPWT 灌流输送套装

K号: K161418 · 2017-01-19

决定日期2017-01-19

产品代码OMP

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

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardinalhealth. It received FDA 510(k) clearance on 2017-01-19 under 510(k) number K161418. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is a medical device that received FDA 510(k) clearance on 2017-01-19. The listed applicant is Cardinalhealth. The 510(k) number is K161418.

When did Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set receive FDA 510(k) clearance?

Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set received FDA 510(k) clearance on 2017-01-19, under 510(k) number K161418.

Who is the listed applicant for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

FDA 510(k)记录显示Cardinalhealth为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set?

The FDA product code for Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set is OMP.

列明Cardinalhealth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。

K261749Cardinal Health 硝基蓝检查手套，经测试可用于化疗药物和芬太尼盐酸盐使用 K252313Cardinal Health 氮化橡胶检查手套，延长袖口 K243660Monoject® 1mL 结核菌素注射器 Luer-Lock 尖端 (1180100777); Monoject® 3mL 注射器，Luer-Lock 尖端 (1180300777); Monoject® 6mL 注射器，Luer-Lock 尖端 (1180600777); Monoject® 12mL 注射器，Luer-Lock 尖端 (1181200777); Monoject® 20mL 注射器，Luer-Lock 尖端 (1182000777); Monoject® 35mL 注射器，Luer-Lock 尖端 (1183500777); Monoject® 60mL 注射器，Luer-Lock 尖端 (1186000777); Monoject® 3mL 注射器，Luer-Lock 尖端 (8881513934); Monoject® 6mL 注射器 , Luer-Lock 尖端 (8881516937); Monojec K243652Monoject® Enteral Syringe with ENFit Connector (401SE); Monoject® Enteral Syringe with ENFit Connector (403SE); Monoject® Enteral Syringe with ENFit Connector (406SE); Monoject® Enteral Syringe with ENFit Connector (412SE); Monoject® Enteral Syringe with ENFit Connector (435SE); Monoject® Enteral Syringe with ENFit Connector (460SE)K230569Cardinal Health防雾水凝胶手术口罩（3级）；Cardinal Health防雾水凝胶手术口罩（1级）K213174Salem Sump 硅胶双腔胃管带 ENFit 连接

查看所有 11 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。