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510(k) Data Aggregation
K Number
K093510Device Name
LUMENVU CATHETER GUIDANCE SYSTEM
Manufacturer
Date Cleared
2010-08-23
(284 days)
Product Code
Regulation Number
880.5970Why did this record match?
Product Code :
OMF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LumenVu™ Catheter Guidance System is intended to aid in the placement of peripherally inserted central catheters (PICC) by providing real-time visual navigation of the catheter tip. The system may be used by trained caregivers in hospitals or other healthcare facilities.
Device Description
The SonoSite LumenVu™ Catheter Guidance System consists of a control box, a display screen, a camera, and a sterile optical stylet. The system uses a near-infrared light source to provide immediate visual feedback to the user on the location of a peripherally inserted central catheter tip. The optical stylet replaces traditional stiffening wire and provides a path for NIR light to its tip.
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K Number
K083121Device Name
NEO MAPCATH SENSOR STYLET
Manufacturer
Date Cleared
2009-02-11
(112 days)
Product Code
Regulation Number
880.5970Why did this record match?
Product Code :
OMF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Device Description
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