Halo One 薄壁引导套管
K号: K212708 · 2021-09-23
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决定日期2021-09-23
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
Halo One Thin-Walled Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212708. 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 Halo One Thin-Walled Guiding Sheath?
Halo One Thin-Walled Guiding Sheath is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K212708.
When did Halo One Thin-Walled Guiding Sheath receive FDA 510(k) clearance?
Halo One Thin-Walled Guiding Sheath received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212708.
Who is the listed applicant for Halo One Thin-Walled Guiding Sheath?
The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Halo One Thin-Walled Guiding Sheath?
The FDA product code for Halo One Thin-Walled Guiding Sheath is DYB.
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列明C.R. Bard, Inc.为申报人的其他记录
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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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