FDA 510(k)

091长鞘，70 cm，091长鞘，80 cm，091长鞘，90 cm

K号: K172468 · 2017-12-06

决定日期2017-12-06

产品代码DQY

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

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm is the device name listed in this FDA 510(k) record. The listed applicant is Inneuroco, Inc.. It received FDA 510(k) clearance on 2017-12-06 under 510(k) number K172468. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm?

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm is a medical device that received FDA 510(k) clearance on 2017-12-06. The listed applicant is Inneuroco, Inc.. The 510(k) number is K172468.

When did 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm receive FDA 510(k) clearance?

091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm received FDA 510(k) clearance on 2017-12-06, under 510(k) number K172468.

Who is the listed applicant for 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm?

The FDA 510(k) record lists Inneuroco, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm?

The FDA product code for 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm is DQY.

列明Inneuroco, 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。

K232260Thinline 套管引入器 K220331091球囊导丝 K190338046 Zenith Flex K181354074 Zenith Flex 系统 K172167Zenith柔韧系统 K173709Zenith Support，95厘米，Zenith Support，105厘米，Zenith Support，115厘米

查看所有 9 个设备 →

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。