FDA 510(k)

Medtronic 6F Taiga 引导导管

K号: K192296 · 2019-09-20

决定日期2019-09-20

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

Medtronic 6F Taiga Guiding Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K192296. 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 Medtronic 6F Taiga Guiding Catheter?

Medtronic 6F Taiga Guiding Catheter is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Medtronic Vascular. The 510(k) number is K192296.

When did Medtronic 6F Taiga Guiding Catheter receive FDA 510(k) clearance?

Medtronic 6F Taiga Guiding Catheter received FDA 510(k) clearance on 2019-09-20, under 510(k) number K192296.

Who is the listed applicant for Medtronic 6F Taiga Guiding Catheter?

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

What is the FDA product code for Medtronic 6F Taiga Guiding Catheter?

The FDA product code for Medtronic 6F Taiga Guiding Catheter is DQY.

列明Medtronic Vascular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。

K232570Steerant® 超硬导丝 K2321906F Sherpa NX 平衡导引导管，7F Sherpa NX 平衡导引导管 K2301565F 启动导丝导管，6F 启动导丝导管，7F 启动导丝导管，8F 启动导丝导管 K220773Everest 20充气装置和三通旋塞（AC2200）；Everest 30充气装置和三通旋塞（AC3200）；包含以下内容的Everest 20生存包：1. Everest 20装置与三通旋塞，2. Piton Y-适配器，3. 金属导丝插入针，4. 扭矩手柄（AC2205P）；Everest 30生存包包含：1. Everest 30装置与三通旋塞，2. Piton Y-适配器，3. 金属导丝插入针，4. 扭矩手柄（AC3205P）K173515Admiral Xtreme K162097InTRAkit

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官方来源

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