FDA 510(k)

Lithoplasty 周边球囊扩张导管；Lithoplasty 发生器和连接电缆；Lithoplasty 连接电缆

K号: K163306 · 2016-12-22

决定日期2016-12-22

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

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable 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 2016-12-22 under 510(k) number K163306. 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 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K163306.

When did Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable receive FDA 510(k) clearance?

Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable received FDA 510(k) clearance on 2016-12-22, under 510(k) number K163306.

Who is the listed applicant for Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

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 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable?

The FDA product code for Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable 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

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官方来源

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