ProCell 外科海绵-血液回收单元
K号: K193361 · 2020-06-01
广告
决定日期2020-06-01
产品代码CAC
咨询委员会AN
请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同
器械摘要
ProCell Surgical Sponge-Blood Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Procell Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193361. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ProCell Surgical Sponge-Blood Recovery Unit?
ProCell Surgical Sponge-Blood Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Procell Surgical, Inc.. The 510(k) number is K193361.
When did ProCell Surgical Sponge-Blood Recovery Unit receive FDA 510(k) clearance?
ProCell Surgical Sponge-Blood Recovery Unit received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193361.
Who is the listed applicant for ProCell Surgical Sponge-Blood Recovery Unit?
The FDA 510(k) record lists Procell Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProCell Surgical Sponge-Blood Recovery Unit?
The FDA product code for ProCell Surgical Sponge-Blood Recovery Unit is CAC.
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。
相关器械（代码：CAC）
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。
K241236XTRA系列套装；XTRA隔离套装Sorin Group Italia S.R.L.K240426Aventus凝血管理系统Inquis MedicalK240584XTRA 自动输血系统（含 XTRA 碗套装）Sorin Group Italia S.R.L.K231782FlowSaver 血液回输系统 (80-101)Inari Medical, Inc.K221483FlowSaver 血液回输系统Inari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation
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。
广告