魏鼻喷管
K号: K211543 · 2022-07-21
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决定日期2022-07-21
产品代码BTR
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
Wei Nasal Jet Tube is the device name listed in this FDA 510(k) record. The listed applicant is Well Lead Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under 510(k) number K211543. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Wei Nasal Jet Tube?
Wei Nasal Jet Tube is a medical device that received FDA 510(k) clearance on 2022-07-21. The listed applicant is Well Lead Medical Co., Ltd.. The 510(k) number is K211543.
When did Wei Nasal Jet Tube receive FDA 510(k) clearance?
Wei Nasal Jet Tube received FDA 510(k) clearance on 2022-07-21, under 510(k) number K211543.
Who is the listed applicant for Wei Nasal Jet Tube?
The FDA 510(k) record lists Well Lead Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wei Nasal Jet Tube?
The FDA product code for Wei Nasal Jet Tube is BTR.
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Well Lead Medical Co., Ltd.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：BTR）
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。
K251794Tenax® 阻激光内窥镜气管导管Bryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ 口腔/鼻腔 RAE 气管导管无领，Murphy 眼 (113-XX) Shiley™ 鼻腔 RAE 气管导管无领，Murphy 眼 (114-XX) Shiley™ 口腔 RAE 气管导管带领，Murphy 眼 (115-XX) Shiley™ 口腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (115-XXOR) Shiley™ 鼻腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (119-XXNR)Covidien, LLCK243785Shiley™ 口腔/鼻腔气管导管带 TaperGuard™ Cuff 加强型，Murphy 眼 Shiley™ 气管导管 TaperGuard™ Cuff 加强型带芯 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型，Murphy 眼 Shiley™ 口腔/鼻腔气管导管无领加强型Covidien, LLCK243579AeroJet 通气导管Pipeline Medical Products, LLCK251499Frova插管引导器（C-CAE-14.0-70-FII）；Frova插管引导器（C-CAE-14.0-70-FI）；Frova插管引导器（C-CAE-14.0-70-FIC）；Frova插管引导器（C-CAE-14.0-70-FIC-SPOPS）William Cook Europe Aps
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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