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FDA 510(k)

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter

K-Number: K151985 · 2016-06-14

ApplicantC.R. Bard, Inc.
Decision Date2016-06-14
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-06-14 under approval number K151985. 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 PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter?

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter is a medical device that received FDA 510(k) clearance on 2016-06-14. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K151985.

When was PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter approved by the FDA?

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter received FDA 510(k) clearance on 2016-06-14, under approval number K151985.

What company makes PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter?

PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter is manufactured by C.R. Bard, Inc..

What is the FDA product code for PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter?

The FDA product code for PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter is LJS.

Other Devices by C.R. Bard, Inc.

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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. K152819Amecath Peripheral inserted Central Venous Catheter SetsAmeco Medical Industries

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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