FDA 510(k)

楔形XL输送导管

K号: K232542 · 2024-05-16

决定日期2024-05-16

产品代码QJP

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

Wedge XL Delivery Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K232542. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wedge XL Delivery Catheter?

Wedge XL Delivery Catheter is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is MicroVention, Inc.. The 510(k) number is K232542.

When did Wedge XL Delivery Catheter receive FDA 510(k) clearance?

Wedge XL Delivery Catheter received FDA 510(k) clearance on 2024-05-16, under 510(k) number K232542.

Who is the listed applicant for Wedge XL Delivery Catheter?

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

What is the FDA product code for Wedge XL Delivery Catheter?

The FDA product code for Wedge XL Delivery Catheter is QJP.

列明MicroVention, 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。

K230775SOFIA EX颅内支撑导管 K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222115ISAAC 神经血管导航导管 K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)K214024SOFIA 88导管 K211120ERIC 检索设备

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官方来源

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