FDA 510(k)

BD Prevue™ II 周围血管通路系统

K号: K240146 · 2024-02-18

决定日期2024-02-18

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

BD Prevue™ II Peripheral Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2024-02-18 under 510(k) number K240146. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BD Prevue™ II Peripheral Vascular Access System?

BD Prevue™ II Peripheral Vascular Access System is a medical device that received FDA 510(k) clearance on 2024-02-18. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K240146.

When did BD Prevue™ II Peripheral Vascular Access System receive FDA 510(k) clearance?

BD Prevue™ II Peripheral Vascular Access System received FDA 510(k) clearance on 2024-02-18, under 510(k) number K240146.

Who is the listed applicant for BD Prevue™ II Peripheral Vascular Access System?

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

What is the FDA product code for BD Prevue™ II Peripheral Vascular Access System?

The FDA product code for BD Prevue™ II Peripheral Vascular Access System is IYO.

列明Bard Access Systems, 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。

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