FDA 510(k)

SeQuent Neo经皮腔内冠状动脉成形术（PTCA）球囊导管

K号: K162625 · 2017-06-12

申请人B. Braun Interventional Systems, Inc.

决定日期2017-06-12

产品代码LOX

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

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162625. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K162625.

When did SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters receive FDA 510(k) clearance?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162625.

Who is the listed applicant for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

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

What is the FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is LOX.

列明B. Braun Interventional Systems, 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。

K152765文纳特克可转换下腔静脉滤器系统

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