FDA 510(k)

POWERWAND 安全导丝带延长停留电极，3Fr. 型号

K号: K162322 · 2016-11-17

决定日期2016-11-17

产品代码DYB

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

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is the device name listed in this FDA 510(k) record. The listed applicant is Access Scientific, LLC. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162322. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Access Scientific, LLC. The 510(k) number is K162322.

When did the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model receive FDA 510(k) clearance?

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162322.

Who is the listed applicant for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model?

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

What is the FDA product code for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model?

The FDA product code for the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model is DYB.

列明Access Scientific, LLC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。

K183066The POWERWAND 安全导引器，配备延长停留导丝，由 ChronoFlex C® 和 BioGUARD™ 技术制成 - 3 Fr，4 Fr 和 5 Fr 型号 K181563ARTERIAL WAND 安全引入器，配备 ChronoFlex C 生物卫士技术动脉导管 K182243CVC WAND安全导引器带瓣可剥套管

相关器械（代码：DYB）

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。

K253526NAMIC 扩张器和套管Medline Industries, LP K261529微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（SIS05C）；微穿刺套件/微穿刺接入套件/微穿刺引导器套装/微引导器套件/微引导器套件（IS01）；引导器套件/微引导器套件/引导器套装/微引导器套装/微引导器鞘套装/引导器鞘套装（NIS04）Hartman Medical Group, LLC K261242SimplGuidePendracare K261950Health Line 可撕开引导器Health Line International Corporation K261492FieldFlex 可弯曲鞘CenterPoint Systems, LLC K260606Echo 大口径引导鞘Echo Medical, LLC

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。