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FDA 510(k)

Intera 非切割（Huber）补充针，Intera 非切割（Huber）特殊推注针和手术室准备包

K号: K211121 · 2021-10-14

申请人Intera Oncology, Inc.
决定日期2021-10-14
产品代码PTI
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

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is the device name listed in this FDA 510(k) record. The listed applicant is Intera Oncology, Inc.. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211121. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Intera Oncology, Inc.. The 510(k) number is K211121.

When did Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit receive FDA 510(k) clearance?

Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211121.

Who is the listed applicant for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

The FDA 510(k) record lists Intera Oncology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit?

The FDA product code for Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit is PTI.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Intera Oncology, Inc.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。

K213823Intera 补充包

相关器械（代码：PTI）

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。

K25409525G 胡贝尔针Martech Medical ProductsK252355K-SHIELD Advantage PORT ACCESS INFUSION SET 带高压软管Sb-Kawasumi Laboratories, Inc.K251138Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.K243332Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max 动力注射输液套件；SafeStep™ Huber 针头套件Bard Access Systems, Inc.K230715Promisemed 安全胡伯针Promisemed Hangzhou Meditech Co., Ltd.

官方来源

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