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FDA 510(k)

PowerPICC Provena Catheters

K-Number: K162443 · 2016-10-25

ApplicantC.R. Bard, Inc.
Decision Date2016-10-25
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PowerPICC Provena Catheters is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162443. 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 Provena Catheters?

PowerPICC Provena Catheters is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K162443.

When did PowerPICC Provena Catheters receive FDA 510(k) clearance?

PowerPICC Provena Catheters received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162443.

Who is the listed applicant for PowerPICC Provena Catheters?

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

What is the FDA product code for PowerPICC Provena Catheters?

The FDA product code for PowerPICC Provena Catheters is LJS.

Related Clinical Trials

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Other records listing C.R. Bard, Inc. as applicant

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Related Devices (Code: LJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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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