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510(k) Data Aggregation
K Number
K180548Device Name
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
Manufacturer
Date Cleared
2018-04-26
(56 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
C.R. Bard, Inc (Bard has joined BD)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Catheter Size Maximum Flow Rate
3 F Single Lumen 3 mL/sec
4 F Dual Lumen 5 mL/sec
Device Description
The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include a silicone valve on the proximal end.
The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.
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