FDA 510(k)

Zenith远端通路长鞘

K号: K253359 · 2026-05-22

申请人Suzhou Zenith Vascular SciTech Limited

决定日期2026-05-22

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

Zenith Distal Access Long Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K253359. 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 Zenith Distal Access Long Sheath?

Zenith Distal Access Long Sheath is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K253359.

When did Zenith Distal Access Long Sheath receive FDA 510(k) clearance?

Zenith Distal Access Long Sheath received FDA 510(k) clearance on 2026-05-22, under 510(k) number K253359.

Who is the listed applicant for Zenith Distal Access Long Sheath?

The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenith Distal Access Long Sheath?

The FDA product code for Zenith Distal Access Long Sheath is QJP.

列明Suzhou Zenith Vascular SciTech Limited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。

K252707Zenith 吸引导管；一次性吸引管套装 K252317Zenith 微导丝 K243534Micro Catheter

官方来源

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