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FDA 510(k)

ProVu单次使用视频风格刀带增强ET管（尺寸6.5）（038-995-065U）；ProVu单次使用视频风格刀带带增强ET管（尺寸7.0）（038-995-070U）；ProVu单次使用视频风格刀带带增强ET管（尺寸7.5）（038-995-075U）；ProVu单次使用视频风格刀带带增强ET管（尺寸8.0）（038-995-080U）

K号: K250243 · 2025-05-20

申请人Flexicare Medical Limited.
决定日期2025-05-20
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

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250243. 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 ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)?

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K250243.

When did ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) receive FDA 510(k) clearance?

ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250243.

Who is the listed applicant for ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)?

FDA 510(k)记录中列出Flexicare Medical Limited.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)?

The FDA product code for ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Flexicare Medical Limited.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。

K2540263.8mm 精薄型 ProVu 视频支气管镜（090-02-0038U）；5.0mm 标准型 ProVu 视频支气管镜（090-02-0050U）；6.0mm 大型 ProVu 视频支气管镜（090-02-0060U）；ProVu 视频支气管镜 8 显示器（040-07-0082U）K251448FL-10000U 呼吸道加湿器K201666一次性压力计K191909HepaShield 细菌病毒呼吸系统过滤器K181583成人一次性复苏器袋（不带压力释放），成人一次性复苏器袋+压力释放40CMH20，成人一次性复苏器袋+压力释放60CMH20，儿童一次性复苏器袋+压力释放40CMH20，婴儿一次性复苏器袋+压力释放40CMH20K163300ThermoShield HME过滤器

查看所有 9 个设备 →

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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