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FDA 510(k)

Silicone Peripherally Inserted Central Venous Catheter Set/Tray

K-Number: K171994 · 2018-02-22

ApplicantCook Incorporated
Decision Date2018-02-22
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Silicone Peripherally Inserted Central Venous Catheter Set/Tray is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-02-22 under approval number K171994. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

Silicone Peripherally Inserted Central Venous Catheter Set/Tray is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Cook Incorporated. The 510(k) number is K171994.

When was Silicone Peripherally Inserted Central Venous Catheter Set/Tray approved by the FDA?

Silicone Peripherally Inserted Central Venous Catheter Set/Tray received FDA 510(k) clearance on 2018-02-22, under approval number K171994.

What company makes Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

Silicone Peripherally Inserted Central Venous Catheter Set/Tray is manufactured by Cook Incorporated.

What is the FDA product code for Silicone Peripherally Inserted Central Venous Catheter Set/Tray?

The FDA product code for Silicone Peripherally Inserted Central Venous Catheter Set/Tray is LJS.

Related Clinical Trials

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Other Devices by Cook Incorporated

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Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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