FDA 510(k)

Pentaflush

K号: K214080 · 2022-07-20

决定日期2022-07-20

产品代码NGT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Pentaflush is the device name listed in this FDA 510(k) record. The listed applicant is Pentaferte Italia S.R.L.. It received FDA 510(k) clearance on 2022-07-20 under 510(k) number K214080. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pentaflush?

Pentaflush is a medical device that received FDA 510(k) clearance on 2022-07-20. The listed applicant is Pentaferte Italia S.R.L.. The 510(k) number is K214080.

When did Pentaflush receive FDA 510(k) clearance?

Pentaflush received FDA 510(k) clearance on 2022-07-20, under 510(k) number K214080.

Who is the listed applicant for Pentaflush?

The FDA 510(k) record lists Pentaferte Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pentaflush?

The FDA product code for Pentaflush is NGT.

列明Pentaferte Italia S.R.L.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。

K211661ENFit 肠内注射器 (NUTRIFIT)K161141ENFit 肠内泵注射器 PENTA ENFit，ENFit 肠内泵注射器 NUTRIFIT

相关器械（代码：NGT）

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。

K2508840.9%氯化钠注射剂，USP，BD PosiFlush® SP注射器Becton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724冲洗注射器（预充0.9%氯化钠溶液）Spm Medicare Pvt. , Ltd.K231363Hantech 预充式 0.9% 生理盐水注射器（型号 PFS-1003, PFS-1005, PFS-1010）Hantech Medical Device Co., Ltd.K223584预充生理盐水冲洗注射器Anhui Tianyang Pharmaceutical Co., Ltd.K230756TK 预充生理盐水冲洗注射器Anhui Tiankang Medical Technology Co., Ltd.

官方来源

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