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510(k) Data Aggregation
K Number
K191827Device Name
Sunmed Disposable Angio-Closure Pads
Manufacturer
Date Cleared
2020-03-16
(252 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Sunny Medical Device (Shenzhen) Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sunmed disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.
Device Description
disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.
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K Number
K160190Device Name
Sunmed Control Syringes
Manufacturer
Date Cleared
2016-11-10
(288 days)
Product Code
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
Sunny Medical Device (Shenzhen) Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.
Device Description
The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use.
The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type.
The volume of two type control syringes that to be offered in 10ml, 12ml.
The sunmed™ Control Syringes are available with rotating male luer and fixed male luer.
The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.
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