牛心包组织补片
K号: K182493 · 2019-06-18
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器械摘要
Bovine Pericardial Tissue Patch is the device name listed in this FDA 510(k) record. The listed applicant is Tisgenx. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K182493. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bovine Pericardial Tissue Patch?
Bovine Pericardial Tissue Patch is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Tisgenx. The 510(k) number is K182493.
When did Bovine Pericardial Tissue Patch receive FDA 510(k) clearance?
Bovine Pericardial Tissue Patch received FDA 510(k) clearance on 2019-06-18, under 510(k) number K182493.
Who is the listed applicant for Bovine Pericardial Tissue Patch?
The FDA 510(k) record lists Tisgenx as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bovine Pericardial Tissue Patch?
The FDA product code for Bovine Pericardial Tissue Patch is FTM.
相关临床试验
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相关器械（代码：FTM）
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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