FDA 510(k)

PROWLER SELECT LP ES 微导管；PROWLER XS 微导管

K号: K214025 · 2022-04-12

决定日期2022-04-12

产品代码KRA

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

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214025. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Medos International SARL. The 510(k) number is K214025.

When did PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter receive FDA 510(k) clearance?

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214025.

Who is the listed applicant for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter?

The FDA product code for PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter is KRA.

列明Medos International SARL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。

K254157CROSSNAV 导航启用工具用于椎间盘准备和椎间 K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ 脊柱系统 K243249TriALTIS™ 脊柱系统 K241893CROSSNAV 导航启用工具和UNAS 导航阵列 K242042TriALTIS™ 脊柱系统

查看所有 75 个设备 →

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。