经皮引导器
K号: K200624 · 2020-04-27
广告
决定日期2020-04-27
产品代码BSO
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
Percutaneous Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200624. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Percutaneous Introducer?
Percutaneous Introducer is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Epimed International, Inc.. The 510(k) number is K200624.
When did Percutaneous Introducer receive FDA 510(k) clearance?
Percutaneous Introducer received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200624.
Who is the listed applicant for Percutaneous Introducer?
The FDA 510(k) record lists Epimed International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Percutaneous Introducer?
The FDA product code for Percutaneous Introducer is BSO.
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Epimed International, 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：BSO）
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。
K241410EDEN ControlCathJmt Co., Ltd.K231242Perifix FX 球囊导管；Contiplex FX 球囊导管B.Braun Medical, Inc.K230603Arrow 非刺激型 SnapLock 适配器 (K-05520-005C)；Arrow 非刺激型下一代 SnapLock 适配器 (Luer 连接) (CA-000010-19)；Arrow 非刺激型下一代 SnapLock 适配器 (神经连接) (CA-000014-19)；Arrow 刺激型 SnapLock 适配器 (带电缆) (TZ-02060-001)；Arrow 刺激型 SnapLock 适配器 (带标签) (TZ-05000-002)Teleflex MedicalK193664SubQKath 导管和针套装Hk SurgicalK191470C-CAT 麻醉导管套装Cimpax ApsK181782Medline 加强型硬脊膜外导管Medline Industries, Inc.
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