FDA 510(k)

Surmodics Sublime Radial Access 014 RX PTA（经皮腔内血管成形术）扩张导管

K号: K200700 · 2020-05-14

决定日期2020-05-14

产品代码LIT

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

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical, Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K200700. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Creagh Medical, Ltd.. The 510(k) number is K200700.

When did Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter receive FDA 510(k) clearance?

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200700.

Who is the listed applicant for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

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

What is the FDA product code for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

The FDA product code for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is LIT.

列明Creagh Medical, Ltd.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。

K230191Arise™ UHP 扩张导管 K180007018 水性涂层 OTW PTA 扩张球囊导管

相关器械（代码：LIT）

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。

K260416ZYLOX 鸭嘴兽 PTA 扩张球囊导管Zylox Medtech Co., Ltd.K254212NC PTA球囊扩张导管Kossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA球囊导管WAVE Medical AG K252512Armada™ 14 NC PTA 导管ABBOTT MEDICAL K251915Amethyst HP PTA OTW 0.035导管Natec Medical , Ltd.K250706Passeo-35 Xeo 周围血管扩张导管；Passeo-18 周围血管扩张导管；Passeo-14 周围血管扩张导管；Oscar 多功能导管系统；Pantera Pro 经皮腔内冠状动脉成形术导管；Pantera LEO 经皮腔内冠状动脉成形术（PTCA）导管Biotronik, Inc.

官方来源

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