FDA 510(k)

Z-6 心房间隔穿刺导管

K号: K211910 · 2021-07-19

决定日期2021-07-19

产品代码DXF

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Z-6 Atrioseptostomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K211910. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Z-6 Atrioseptostomy Catheter?

Z-6 Atrioseptostomy Catheter is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is NuMED, Inc.. The 510(k) number is K211910.

When did Z-6 Atrioseptostomy Catheter receive FDA 510(k) clearance?

Z-6 Atrioseptostomy Catheter received FDA 510(k) clearance on 2021-07-19, under 510(k) number K211910.

Who is the listed applicant for Z-6 Atrioseptostomy Catheter?

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

What is the FDA product code for Z-6 Atrioseptostomy Catheter?

The FDA product code for Z-6 Atrioseptostomy Catheter is DXF.

列明NuMED, 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。

K213915BIB支架置入导管 K211134BIB支架置入导管 K190974D'Vill导丝 K171206D'Vill导丝 K161451BIB支架置入导管 K160598REBOA Balloon Catheter

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相关器械（代码：DXF）

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。

K261745LightningWire经隔膜穿刺系统（TPS）ElectroWire Medical K253799SafeSept RF 经隔膜导丝（SSRF132；SSRF132R；SSRF232；SSRF232R；SSRF135；SSRF135R；SSRF235；SSRF235R）Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）Atraverse Medical K252419HOTWIRE RF 导丝（901XXX）；HOTWIRE RF 导丝（902XXX）Atraverse Medical, Inc.K251007CrossWise RF 经隔膜通路系统（型号：CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F）Circa Scientific, Inc.K243193Cross Wise® 多用 RF 适配器电缆Circa Scientific, Inc.

官方来源

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