FDA 510(k)

再处理ViewFlex Xtra ICE导管（D087031）

K号: K231621 · 2023-07-25

决定日期2023-07-25

产品代码OWQ

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

Reprocessed ViewFlex Xtra ICE Catheter (D087031) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K231621. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reprocessed ViewFlex Xtra ICE Catheter (D087031)?

Reprocessed ViewFlex Xtra ICE Catheter (D087031) is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K231621.

When did Reprocessed ViewFlex Xtra ICE Catheter (D087031) receive FDA 510(k) clearance?

Reprocessed ViewFlex Xtra ICE Catheter (D087031) received FDA 510(k) clearance on 2023-07-25, under 510(k) number K231621.

Who is the listed applicant for Reprocessed ViewFlex Xtra ICE Catheter (D087031)?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed ViewFlex Xtra ICE Catheter (D087031)?

The FDA product code for Reprocessed ViewFlex Xtra ICE Catheter (D087031) is OWQ.

列明Stryker Sustainability Solutions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。

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查看所有 25 个设备 →

相关器械（代码：OWQ）

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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