FDA 510(k)

BD PowerPiCC Catheter

K-Number: K210264 · 2021-07-30

Decision Date2021-07-30

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

BD PowerPiCC Catheter is a medical device manufactured by Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2021-07-30 under approval number K210264. 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 BD PowerPiCC Catheter?

BD PowerPiCC Catheter is a medical device that received FDA 510(k) clearance on 2021-07-30. It is manufactured by Bard Access Systems, Inc.. The 510(k) number is K210264.

When was BD PowerPiCC Catheter approved by the FDA?

BD PowerPiCC Catheter received FDA 510(k) clearance on 2021-07-30, under approval number K210264.

What company makes BD PowerPiCC Catheter?

BD PowerPiCC Catheter is manufactured by Bard Access Systems, Inc..

What is the FDA product code for BD PowerPiCC Catheter?

The FDA product code for BD PowerPiCC Catheter is LJS.

Other Devices by Bard Access Systems, Inc.

K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly K241353PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set K242328PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports K240146BD Prevue II Peripheral Vascular Access System K252478Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port K251253PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port

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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

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