FDA 510(k)

球关节引导阵列（66295）

K号: K250893 · 2025-09-04

决定日期2025-09-04

产品代码HAW

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Ball Joint Guide Array (66295) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K250893. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ball Joint Guide Array (66295)?

Ball Joint Guide Array (66295) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K250893.

When did Ball Joint Guide Array (66295) receive FDA 510(k) clearance?

Ball Joint Guide Array (66295) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K250893.

Who is the listed applicant for Ball Joint Guide Array (66295)?

The FDA 510(k) record lists Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ball Joint Guide Array (66295)?

The FDA product code for Ball Joint Guide Array (66295) is HAW.

列明Bayer Medical Care, 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。

K253688MEDRAD® 成像大批量包装转移针头 K252891MEDRAD MRXperion MR 注射系统及 MR 注射系统注射器套件；MEDRAD ISI2 模块（ISI2）K200280MEDRAD 成像大批量包装转移针头 K192370MEDRAD Stellant FLEX CT 注射系统带 Certegra 工作站 K193028MEDRAD Mark 7 Arterion 注射系统 K182273MEDRAD Stellant FLEX CT 注射系统带 Certegra 工作站，MEDRAD Stellant FLEX 注射器套件，MEDRAD Stellant CT 注射系统带 Certegra 工作站，MEDRAD Stellant 注射器套件，MEDRAD Stellant 连接管，P3T 心脏，P3T 肺动脉，P3T 腹部，ISI，Connect.CT

查看所有 9 个设备 →

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。