FDA 510(k)

Scoreflex PTA评分球囊导管

K号: K182713 · 2019-06-11

决定日期2019-06-11

产品代码PNO

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

Scoreflex PTA Scoring Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K182713. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Scoreflex PTA Scoring Balloon Catheter?

Scoreflex PTA Scoring Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K182713.

When did Scoreflex PTA Scoring Balloon Catheter receive FDA 510(k) clearance?

Scoreflex PTA Scoring Balloon Catheter received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182713.

Who is the listed applicant for Scoreflex PTA Scoring Balloon Catheter?

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

What is the FDA product code for Scoreflex PTA Scoring Balloon Catheter?

The FDA product code for Scoreflex PTA Scoring Balloon Catheter is PNO.

列明Orbusneich Medical Trading, 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。

K200269Sapphire II PRO K192344Sapphire NC Plus 冠状动脉扩张导管 K182360Teleport 微导管 K180921Sapphire II PRO 气球扩张导管 K173680Sapphire II PRO K173894Jade PTA 拓张球囊导管

查看所有 7 个设备 →

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。