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FDA 510(k)

Passeo-35 Xeo周围扩张导管

K号: K222065 · 2023-02-16

申请人Biotronik, Inc.
决定日期2023-02-16
产品代码LIT
咨询委员会CV
决定Substantially Equivalent

器械摘要

Passeo-35 Xeo Peripheral Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2023-02-16 under 510(k) number K222065. 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 Passeo-35 Xeo Peripheral Dilatation Catheter?

Passeo-35 Xeo Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-02-16. The listed applicant is Biotronik, Inc.. The 510(k) number is K222065.

When did Passeo-35 Xeo Peripheral Dilatation Catheter receive FDA 510(k) clearance?

Passeo-35 Xeo Peripheral Dilatation Catheter received FDA 510(k) clearance on 2023-02-16, under 510(k) number K222065.

Who is the listed applicant for Passeo-35 Xeo Peripheral Dilatation Catheter?

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

What is the FDA product code for Passeo-35 Xeo Peripheral Dilatation Catheter?

The FDA product code for Passeo-35 Xeo Peripheral 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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (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Biotronik, 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。

K261074BIOMONITOR IV（471155）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K242969Pantera Pro; Pantera LEOK240787Selectra 3D 导线递送系统（443624-443629，451789-451791）；Selectra 切割工具（383119）；Selectra 配件套件（375518）K241711Oscar 外周多功能导管系统K230375BIOMONITOR IV

查看所有 23 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 Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE 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

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