FDA 510(k)

DuraSheath引导鞘系统

K号: K181463 · 2018-12-13

决定日期2018-12-13

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： --- 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

DuraSheath Introducer Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical International, GmbH. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K181463. 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 DuraSheath Introducer Sheath System?

DuraSheath Introducer Sheath System is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Contract Medical International, GmbH. The 510(k) number is K181463.

When did DuraSheath Introducer Sheath System receive FDA 510(k) clearance?

DuraSheath Introducer Sheath System received FDA 510(k) clearance on 2018-12-13, under 510(k) number K181463.

Who is the listed applicant for DuraSheath Introducer Sheath System?

The FDA 510(k) record lists Contract Medical International, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraSheath Introducer Sheath System?

The FDA product code for DuraSheath Introducer Sheath System is DYB.

列明Contract Medical International, GmbH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。

K250439Catapult引导鞘；4F；15cm（US-34015-F-ST-H）；Catapult引导鞘；4F；45cm（US-34045-F-ST-H）；Catapult引导鞘；4F；60cm（US-34060-F-ST-H）；Catapult引导鞘；4F；90cm（US-34090-F-ST-H）；Catapult引导鞘；4F；130cm（US-34130-F-ST-H）；Catapult引导鞘；5F；15cm（US-35015-F-ST-H）；Catapult引导鞘；5F；45cm（US-35045-F-ST-H）；Catapult引导鞘；5F；45cm；曲棍球棒（US-35045-F-HS-H）；Catapult引导鞘；5F；45cm；多功能（US-35045-F-MP-H）；Ca K240957Catapult引导鞘 K221914Catapult引导鞘 K203179Fortress Introducer Sheath System K153197Fortress Introducer Sheath System

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

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