FDA 510(k)

ProtekDilate 血管通路套件

K号: K253616 · 2025-12-19

决定日期2025-12-19

产品代码DRE

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

ProtekDilate Vascular Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253616. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ProtekDilate Vascular Access Kit?

ProtekDilate Vascular Access Kit is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K253616.

When did ProtekDilate Vascular Access Kit receive FDA 510(k) clearance?

ProtekDilate Vascular Access Kit received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253616.

Who is the listed applicant for ProtekDilate Vascular Access Kit?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProtekDilate Vascular Access Kit?

The FDA product code for ProtekDilate Vascular Access Kit is DRE.

列明Sorin Group Italia S.R.L.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。

K253671双阶段静脉导管 K251783Inspire HCR和HCR DUAL心脏切开储液器 K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装）；VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装带分流）；VANGUARD 血液心肌保护系统（Vanguard 4:1 血液心肌保护套装迷你版）K243264DHF 0.2 血液浓缩器（DHF 02）；DHF 0.6 血液浓缩器（DHF 06）；SH 14 血液浓缩器（SH 14）K242953KIDS动脉过滤器

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官方来源

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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。