Frova插管引导器
K号: K161813 · 2017-05-19
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决定日期2017-05-19
产品代码BTR
咨询委员会AN
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决定实质等同
器械摘要
Frova Intubating Introducer is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2017-05-19 under 510(k) number K161813. 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 Frova Intubating Introducer?
Frova Intubating Introducer is a medical device that received FDA 510(k) clearance on 2017-05-19. The listed applicant is William Cook Europe Aps. The 510(k) number is K161813.
When did Frova Intubating Introducer receive FDA 510(k) clearance?
Frova Intubating Introducer received FDA 510(k) clearance on 2017-05-19, under 510(k) number K161813.
Who is the listed applicant for Frova Intubating Introducer?
The FDA 510(k) record lists William Cook Europe Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Frova Intubating Introducer?
The FDA product code for Frova Intubating Introducer 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William Cook Europe Aps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。
K251596Lunderquist 额外硬质导丝K251499Frova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）K233680Celect Platinum 股静脉滤器套装 (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum 颈静脉滤器套装 (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum 股静脉和颈静脉滤器套装 (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip 股静脉滤器套装 (IGTCFS-65-1-FEM-TULIP); Günther Tulip 颈静脉滤器套装 (IGTCFS-65-1-JUG-TULIP); Günther Tulip 静脉滤器K220137Lunderquist 额外硬质导丝K211875Cook Celect Platinum 股静脉途径下腔静脉滤器套装，Cook Celect Platinum 颈静脉途径下腔静脉滤器套装，Cook Celect Platinum 股静脉和颈静脉途径下腔静脉滤器套装K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
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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