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510(k) Data Aggregation
K Number
K043235Device Name
DRAGON HEART I.V. SET
Manufacturer
Date Cleared
2005-03-08
(106 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
DRAGON HEART MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Device Description
Not Found
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K Number
K042547Device Name
DRAGON HEART PISTON SYRINGE
Manufacturer
Date Cleared
2004-12-01
(72 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
DRAGON HEART MEDICAL DEVICES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
Device Description
The syringe has a graduated barrel, a plunger, a hub and a needle.
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