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510(k) Data Aggregation
K Number
K121511Device Name
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
Manufacturer
Date Cleared
2013-03-07
(290 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MACLIN POWER INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Device Description
The Maclin Power Intravascular Administration Sets are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include one or more of the following: tubing, flow regulators, drip chamber, filters, backflow valves, fluid delivery tubing, clamps, connectors between parts of the set, needleless connectors, needleless Y sites, burettes, extension sets, Y tubing connector, protection caps and a hollow spike to connect the tubing to an IV bag or other infusion fluid container. Maclin Power will offer both standard sets and custom sets to meet customer specifications.
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