FDA 510(k)

重新处理过的可操纵导引器

K号: K152090 · 2016-03-23

决定日期2016-03-23

产品代码PNE

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

Reprocessed Steerable Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152090. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed Steerable Introducer?

Reprocessed Steerable Introducer is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Sterilmed, Inc.. The 510(k) number is K152090.

When did Reprocessed Steerable Introducer receive FDA 510(k) clearance?

Reprocessed Steerable Introducer received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152090.

Who is the listed applicant for Reprocessed Steerable Introducer?

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

What is the FDA product code for Reprocessed Steerable Introducer?

The FDA product code for Reprocessed Steerable Introducer is PNE.

列明Sterilmed, 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。

K254149再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510825）；再生AcuNav CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657484）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于西门子系统（R11510826）；再生SOUNDSTAR CRYSTAL™超声导管9F x 90 CM，适用于GE系统（R11657485）K240826再生处理DECANAV™电生理导管；再生处理WEBSTER®双极电生理导管 K190478再处理ViewFlex™ Xtra ICE导管 K190610再处理的HARMONIC FOCUS剪 + 自适应组织技术 K182272再处理的HARMONIC ACE+ 7剪，具有高级止血功能 K161700SoundStar eco 8F 3D 诊断 eco 超声波导管，SoundStar eco 8F G 3D 诊断 eco 超声波导管

查看所有 10 个设备 →

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。