FDA 510(k)

POWERPICC

K-Number: K051672 · 2005-11-23

Decision Date2005-11-23

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWERPICC is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2005-11-23 under 510(k) number K051672. 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?

POWERPICC is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K051672.

When did POWERPICC receive FDA 510(k) clearance?

POWERPICC received FDA 510(k) clearance on 2005-11-23, under 510(k) number K051672.

Who is the listed applicant for POWERPICC?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERPICC?

The FDA product code for POWERPICC is LJS.

Related Clinical Trials

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Other records listing Bard Access Systems, Inc. as applicant

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 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 K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular K252792PM2™ 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.

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.