FDA 510(k)

韦尔奇·艾略恩FlexiPort血压袖带（FlexiPort血压袖带）

K号: K251745 · 2025-12-16

决定日期2025-12-16

产品代码DXQ

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

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K251745. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K251745.

When did Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) receive FDA 510(k) clearance?

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251745.

Who is the listed applicant for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)?

The FDA product code for Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) is DXQ.

列明Baxter Healthcare Corporation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。

K251636Spectrum IQ 注射系统，配备剂量 IQ 安全软件（3570009）K251640SIGMA Spectrum 输液泵带主药物库 K243529Solution Administration Sets K242339Intravascular Extension Sets and Accessories K242390Novum IQ 注射泵（40800BAXUS）K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS

查看所有 44 个设备 →

相关器械（代码：DXQ）

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。

K254287Medline 可重复使用血压袖带Medline Industries, LP K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带Nihon Kohden Corporation K253089NIBP袖带（BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722）Shenzhen Best Electronics Co., Ltd.K253964一次性新生儿NIBP袖带（U1681S-C51N）Unimed Medical Supplies, Inc.K250765AViTA 臂式血压计袖带Avita Corporation K251045一次性新生儿NIBP袖带（U1682S-C51N）；一次性新生儿NIBP袖带（U1683S-C51N）；一次性新生儿NIBP袖带（U1684S-C51N）；一次性新生儿NIBP袖带（U1685S-C51N）Unimed Medical Supplies, 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。