WAVE PTA球囊导管
K号: K260304 · 2026-05-20
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决定日期2026-05-20
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：
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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]
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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
WAVE PTA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is WAVE Medical AG. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K260304. 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 WAVE PTA Balloon Catheter?
WAVE PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is WAVE Medical AG. The 510(k) number is K260304.
When did WAVE PTA Balloon Catheter receive FDA 510(k) clearance?
WAVE PTA Balloon Catheter received FDA 510(k) clearance on 2026-05-20, under 510(k) number K260304.
Who is the listed applicant for WAVE PTA Balloon Catheter?
The FDA 510(k) record lists WAVE Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WAVE PTA Balloon Catheter?
The FDA product code for WAVE PTA Balloon 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。
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.K252512Armada™ 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.K243704Parafleet 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Brosmed Medical Co., Ltd.
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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