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510(k) Data Aggregation
K Number
K160747Device Name
Angel Catheter
Manufacturer
Date Cleared
2016-07-28
(132 days)
Product Code
Regulation Number
870.3375Why did this record match?
Product Code :
PNS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Angel® Catheter is intended to provide the combined functions of an inferior vena cava (IVC) filter and a multilumen central venous catheter.
The Angel® Catheter is intended for short term use for the prevention of clinically significant pulmonary embolism (PE) in critically ill patients at high risk for PE or recognized contraindications to standard pharmacological thromboprophylaxis therapy.
The Angel® Catheter is also intended to provide access to the central venous system.
Device Description
The Angel® Catheter is a retrievable vena cava filter permanently attached to a central venous access catheter. The conical, self-expanding, Nitinol filter has wide proximal openings that allow the capture of clots in the distal end of the filter. The filter is 50 mm long at its maximum expanded/unconstrained diameter of 30 mm. The distal end of the filter is free floating on the central venous catheter so that the filter can expand to the diameter of the vena cava.
The catheter is designed to constrain the IVC filter component in an unexpanded state for delivery to the IVC and to function as the sheath for retrieval of the IVC filter. It has '1 cm' depth markers indicating the depth the catheter has been inserted into the patient. For ease of placement, the catheter has a hydrophilic coating applied to the outer diameter up to the 24 cm depth marker.
The filter is permanently attached to the multi-lumen catheter to ensure secure positioning, while simultaneously providing access to the central venous system for administration of medications, fluids, or blood products; blood sampling; and monitoring of central venous pressure. The multi-lumen catheter and sheath connections are standard color-coded luer fittings, compatible with current ICU pressure monitoring equipment and other accessories. The Distal Tip Port and Proximal Sheath Port may be used for power injection of contrast media, and these luers contain specific pad printing indicating the maximum power injection rates.
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