Turbo-Flo PICC Sets
K号: K161496 · 2016-10-07
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器械摘要
Turbo-Flo PICC Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-10-07 under 510(k) number K161496. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Turbo-Flo PICC Sets?
Turbo-Flo PICC Sets is a medical device that received FDA 510(k) clearance on 2016-10-07. The listed applicant is Cook Incorporated. The 510(k) number is K161496.
When did Turbo-Flo PICC Sets receive FDA 510(k) clearance?
Turbo-Flo PICC Sets received FDA 510(k) clearance on 2016-10-07, under 510(k) number K161496.
Who is the listed applicant for Turbo-Flo PICC Sets?
The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Turbo-Flo PICC Sets?
The FDA product code for Turbo-Flo PICC Sets is LJS.
相关临床试验
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列明Cook Incorporated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。
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相关器械（代码：LJS）
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。
K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.
官方来源
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