Pacel 流导向起搏导管
K号: K161873 · 2016-11-22
广告
决定日期2016-11-22
产品代码LDF
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
Pacel Flow Directed Pacing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161873. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pacel Flow Directed Pacing Catheter?
Pacel Flow Directed Pacing Catheter is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is St Jude Medical. The 510(k) number is K161873.
When did Pacel Flow Directed Pacing Catheter receive FDA 510(k) clearance?
Pacel Flow Directed Pacing Catheter received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161873.
Who is the listed applicant for Pacel Flow Directed Pacing Catheter?
The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pacel Flow Directed Pacing Catheter?
The FDA product code for Pacel Flow Directed Pacing Catheter is LDF.
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。
列明St Jude Medical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。
相关器械（代码：LDF）
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。
K252042同步AV II 临时起搏导管Swift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® 临时起搏电极导管 针/管 (引入器)C.R. Bard, Inc.K241334半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，4Fr.（006221P）；半浮动临时起搏电极导管，双极，不锈钢电极，115厘米，5Fr.（006225P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，6Fr.（006241P）；半浮动临时起搏电极导管，双极，不锈钢电极，125厘米，7Fr.（006242P）；NBIH™临时起搏电极导管C.R. Bard, Inc.K241199可旋转连接器（5944RL）Shenzhen Launch Electrical Co., Ltd.K242705Streamline 单极儿科临时起搏导线（6491）Streamline 单极临时心房起搏导线（6492）Streamline 单极临时心肌起搏导线（6494）Streamline 双极临时心肌起搏导线（6495）Streamline 单极临时心肌起搏导线（6500）Medtronic, 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。
广告