FDA 510(k)

SABER .035 经皮腔内血管成形术 (PTA) 扩张导管

K号: K210626 · 2021-04-23

决定日期2021-04-23

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

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corporation. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210626. 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 SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Cordis Corporation. The 510(k) number is K210626.

When did SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter receive FDA 510(k) clearance?

SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210626.

Who is the listed applicant for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

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

What is the FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter?

The FDA product code for SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter is LIT.

列明Cordis Corporation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。

K220654ANGIOGUARD XP 脂肪栓捕获导丝，ANGIOGUARD RX 脂肪栓捕获导丝 K212977SUPER 扭矩 MB 影像导管，带不透射线标记带 K202167Brite Tip Radianz Guiding Sheath K201377SABERX RADIANZ 经皮腔内血管成形术扩张导管 K201333SABER .035 PTA 扩张导管 K181592RAIN 套管经桡动脉

查看所有 8 个设备 →

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

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。