FDA 510(k)

ENROUTE Enflate 转颈动脉 RX 扩张球囊导管

K号: K221414 · 2022-09-02

决定日期2022-09-02

产品代码LIT

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

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Silk Road Medical, Inc.. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K221414. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Silk Road Medical, Inc.. The 510(k) number is K221414.

When did ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter receive FDA 510(k) clearance?

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221414.

Who is the listed applicant for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

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

What is the FDA product code for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter?

The FDA product code for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter is LIT.

列明Silk Road Medical, 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。

K153485ENROUTE 转颈动脉神经保护系统

相关器械（代码：LIT）

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。

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官方来源

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