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FDA 510(k)

Parafleet SC 014 PTA球囊扩张导管；Parafleet SC 018 PTA球囊扩张导管；Parafleet SC 035 PTA球囊扩张导管

K号: K243704 · 2025-02-27

申请人Brosmed Medical Co., Ltd.
决定日期2025-02-27
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

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-02-27 under 510(k) number K243704. 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 Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter?

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2025-02-27. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K243704.

When did Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2025-02-27, under 510(k) number K243704.

Who is the listed applicant for Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter?

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

What is the FDA product code for Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter?

The FDA product code for Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter is LIT.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Brosmed Medical Co., 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。

K241478三楔形PTA评分球囊扩张导管K230705POT PTCA 球囊扩张导管K212215Tiche PTA球囊扩张导管K203390Artimes pro Balloon Dilatation CatheterK160941Castor、Achilles 和 Hermes NC PTA 气球扩张导管K153742Apollo 气球扩张导管

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 AGK252512Armada™ 14 NC PTA 导管ABBOTT MEDICALK251915Amethyst 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。

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