FDA 510(k)

SecurePortIV Advanced Catheter Securement Adhesive

K号: K223669 · 2023-06-12

决定日期2023-06-12

产品代码NZP

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决定实质等同

器械摘要

SecurePortIV Advanced Catheter Securement Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Adhezion Biomedical, LLC. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K223669. The device is classified under product code NZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SecurePortIV Advanced Catheter Securement Adhesive?

SecurePortIV Advanced Catheter Securement Adhesive is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Adhezion Biomedical, LLC. The 510(k) number is K223669.

When did SecurePortIV Advanced Catheter Securement Adhesive receive FDA 510(k) clearance?

SecurePortIV Advanced Catheter Securement Adhesive received FDA 510(k) clearance on 2023-06-12, under 510(k) number K223669.

Who is the listed applicant for SecurePortIV Advanced Catheter Securement Adhesive?

The FDA 510(k) record lists Adhezion Biomedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SecurePortIV Advanced Catheter Securement Adhesive?

The FDA product code for SecurePortIV Advanced Catheter Securement Adhesive is NZP.

列明Adhezion Biomedical, LLC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。

K170505SecurePortIV Catheter Securement Adhesive K161011SURGISEAL 表面皮肤粘合剂，SURGISEAL 针式表面皮肤粘合剂，SURGISEAL 扭曲表面皮肤粘合剂

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。