Impella XR 套管套装
K号: K202330 · 2020-12-07
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决定日期2020-12-07
产品代码DYB
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：
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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
Impella XR Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K202330. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Impella XR Sheath Set?
Impella XR Sheath Set is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Abiomed, Inc.. The 510(k) number is K202330.
When did Impella XR Sheath Set receive FDA 510(k) clearance?
Impella XR Sheath Set received FDA 510(k) clearance on 2020-12-07, under 510(k) number K202330.
Who is the listed applicant for Impella XR Sheath Set?
The FDA 510(k) record lists Abiomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Impella XR Sheath Set?
The FDA product code for Impella XR Sheath Set is DYB.
相关临床试验
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。
列明Abiomed, 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。
相关器械（代码：DYB）
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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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。
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