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FDA 510(k)

泰维克自封袋带STERRAD化学指示剂，泰维克卷材带STERRAD化学指示剂，泰维克热封袋带STERRAD化学指示剂

K号: K163598 · 2017-07-31

申请人Advanced Sterilization Products
决定日期2017-07-31
产品代码KCT
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

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K163598. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator?

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Advanced Sterilization Products. The 510(k) number is K163598.

When did Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator receive FDA 510(k) clearance?

Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator received FDA 510(k) clearance on 2017-07-31, under 510(k) number K163598.

Who is the listed applicant for Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator?

The FDA 510(k) record lists Advanced Sterilization Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator?

The FDA product code for Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator is KCT.

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Advanced Sterilization Products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。

K234082STERRAD® 100NX 消毒器，配备 ALLClear® 技术和 ULTRA GI® 循环（10104）；APTIMAX® 仪器托盘，用于 ULTRA GI® 循环（011077）K162007STERRAD NX 消毒器K160818STERRAD® NX 消毒器，配备 ALLClear® 技术K160903STERRAD 100NX 消毒器，配备 ALLClearTM 技术K151725STERRAD NX 消毒器，STERRAD 100NX 消毒器

相关器械（代码：KCT）

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。

K253988LiteSet托盘Nobel Biocare ABK261935外科和假肢托盘Dentsply Sirona, Inc.K253187SteriBest® 消毒托盘系统Mastel SurgicalK252854SteriTite 容器系统与 MediTray 产品Case Medical, Inc.K260726Straumann® ProClean™托盘（041.800；041.801）Institut Straumann AGK253791PUREVUE™ 快速连接导管系统托盘；PUREVUE™ 快速连接导管系统盖DePuy Mitek, Inc.

官方来源

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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。

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