Stiletto 延长停留导管
K号: K210047 · 2021-08-27
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决定日期2021-08-27
产品代码PND
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
Stiletto Extended Dwell Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210047. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Stiletto Extended Dwell Catheter?
Stiletto Extended Dwell Catheter is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Piper Access, LLC. The 510(k) number is K210047.
When did Stiletto Extended Dwell Catheter receive FDA 510(k) clearance?
Stiletto Extended Dwell Catheter received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210047.
Who is the listed applicant for Stiletto Extended Dwell Catheter?
The FDA 510(k) record lists Piper Access, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stiletto Extended Dwell Catheter?
The FDA product code for Stiletto Extended Dwell Catheter is PND.
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。
列明Piper Access, LLC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。
相关器械（代码：PND）
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。
K252402中线导管Terumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow 压力注射中线导管Arrow International, LLC Subsidiary of Teleflex IncorporatedK213203Provena™ 中线导管C.R. Bard, Inc.K192802primeMidline 导管Pfm Medical, Inc.K181208Vygon 中线 3 Fr SL 管道；Vygon 中线 4 Fr SL 管道；Vygon 中线 5 Fr DL 管道Vygon USAK173114primeMidline 导管Pfm Medical, Inc.
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。
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