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510(k) Data Aggregation
K Number
K190012Device Name
OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid
Manufacturer
Medtrade Product Ltd
Date Cleared
2019-12-18
(349 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Medtrade Product Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French
CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French
Device Description
OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved.
OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.
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