维斯塔BC密封器
K号: K221811 · 2022-11-21
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决定日期2022-11-21
产品代码KIF
咨询委员会DE
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决定实质等同
器械摘要
Vista BC Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med, Inc.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K221811. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vista BC Sealer?
Vista BC Sealer is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Inter-Med, Inc.. The 510(k) number is K221811.
When did Vista BC Sealer receive FDA 510(k) clearance?
Vista BC Sealer received FDA 510(k) clearance on 2022-11-21, under 510(k) number K221811.
Who is the listed applicant for Vista BC Sealer?
The FDA 510(k) record lists Inter-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vista BC Sealer?
The FDA product code for Vista BC Sealer is KIF.
相关临床试验
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。
列明Inter-Med, 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。
相关器械（代码：KIF）
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。
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。
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