FDA 510(k)

外周血管内碎石术（IVL）导管，IVL发生器和连接电缆套件，IVL连接电缆（替换件）

K号: K191840 · 2019-08-07

决定日期2019-08-07

产品代码PPN

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

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K191840. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K191840.

When did Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) receive FDA 510(k) clearance?

Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191840.

Who is the listed applicant for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

FDA 510(k)记录中列出Shockwave Medical, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)?

The FDA product code for Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) is PPN.

列明Shockwave Medical, 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。

K262201带有Shockwave E8 周边IVL 导管的Shockwave 经血管内碎石术（IVL）系统 K243757Shockwave CS 引导导管 K242213带有Javelin 周边血管内碎石术（IVL）导管的Shockwave 经血管内碎石术（IVL）系统 K240954带有Shockwave L6 周边IVL 导管的Shockwave 经血管内碎石术（IVL）系统 K240225带有Shockwave E8 周边IVL 导管的Shockwave 经血管内碎石术（IVL）系统 K221852带有Shockwave L6 周边IVL 导管的Shockwave 经血管内碎石术（IVL）系统

查看所有 13 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。