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510(k) Data Aggregation
K Number
K162601Device Name
Infusion Set for Single Use
Manufacturer
Date Cleared
2017-05-31
(254 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is indicated for the delivery of fluids from a container to a patient's vascular system.
Device Description
The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.
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