FDA 510(k)

MEDRAD® 成像大批量包装转移针头

K号: K253688 · 2026-06-12

决定日期2026-06-12

产品代码PQH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

MEDRAD® Imaging Bulk Package Transfer Spike 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 2026-06-12 under 510(k) number K253688. The device is classified under product code PQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MEDRAD® Imaging Bulk Package Transfer Spike?

MEDRAD® Imaging Bulk Package Transfer Spike is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Bayer Medical Care, Inc.. The 510(k) number is K253688.

When did MEDRAD® Imaging Bulk Package Transfer Spike receive FDA 510(k) clearance?

MEDRAD® Imaging Bulk Package Transfer Spike received FDA 510(k) clearance on 2026-06-12, under 510(k) number K253688.

Who is the listed applicant for MEDRAD® Imaging Bulk Package Transfer Spike?

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 MEDRAD® Imaging Bulk Package Transfer Spike?

The FDA product code for MEDRAD® Imaging Bulk Package Transfer Spike is PQH.

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。

K252891MEDRAD MRXperion MR 注射系统及 MR 注射系统注射器套件；MEDRAD ISI2 模块（ISI2）K250893球关节引导阵列（66295）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。