FDA 510(k)

Esperance 3+ 吸痰导管系统

K号: K240917 · 2024-10-01

决定日期2024-10-01

产品代码NRY

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

Esperance 3+ Aspiration Catheter System is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2024-10-01 under 510(k) number K240917. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Esperance 3+ Aspiration Catheter System?

Esperance 3+ Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Wallaby Medical. The 510(k) number is K240917.

When did Esperance 3+ Aspiration Catheter System receive FDA 510(k) clearance?

Esperance 3+ Aspiration Catheter System received FDA 510(k) clearance on 2024-10-01, under 510(k) number K240917.

Who is the listed applicant for Esperance 3+ Aspiration Catheter System?

FDA 510(k)记录将Wallaby Medical列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Esperance 3+ Aspiration Catheter System?

The FDA product code for Esperance 3+ Aspiration Catheter System is NRY.

列明Wallaby Medical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。

K254071p17 XR 微导管 K231056Esperance 远端通路导管 K232437Paragon 8F 气球引导导管 K223139袋鼠017微导管 K211697Esperance 吸痰导管系统

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。