FDA 510(k)

NexSite® HD 长期使用阶梯尖端血液透析导管（24cm，28cm，32cm，36cm，40cm，55cm）

K号: K161026 · 2016-08-09

决定日期2016-08-09

产品代码MSD

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) is the device name listed in this FDA 510(k) record. The listed applicant is Marvao Medical Devices, Ltd.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K161026. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)?

NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Marvao Medical Devices, Ltd.. The 510(k) number is K161026.

When did NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) receive FDA 510(k) clearance?

NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) received FDA 510(k) clearance on 2016-08-09, under 510(k) number K161026.

Who is the listed applicant for NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)?

The FDA 510(k) record lists Marvao Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)?

The FDA product code for NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) is MSD.

列明Marvao Medical Devices, Ltd.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。

K220632Boss Crossing 支撑导丝 K173805NexSite HD 长期使用对称尖端血液透析导管（19cm），NexSite HD 长期使用对称尖端血液透析导管（23cm），NexSite HD 长期使用对称尖端血液透析导管（27cm），NexSite HD 长期使用对称尖端血液透析导管（31cm），NexSite HD 长期使用对称尖端血液透析导管（35cm），NexSite HD 长期使用对称尖端血液透析导管（55cm）K171571NexSite HD，60cm 血液透析阶梯尖端导管

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。