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510(k) Data Aggregation
K Number
K101368Device Name
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
Manufacturer
Date Cleared
2010-11-18
(185 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
DRAGON HEART MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
D. Heart Medical intravascular administration set, safety access device and accessories are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Device Description
Each device is comprised of components commonly found in intravascular administration sets and extension sets. Incorporation of safety access device aid in the prevention of accidental needle sticks to healthcare workers and patients.
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