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510(k) Data Aggregation
K Number
K050600Device Name
MINILOC SAFETY INFUSION SET
Manufacturer
SPECIALIZED HEALTH PRODUCTS, INTL.
Date Cleared
2005-05-12
(64 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SPECIALIZED HEALTH PRODUCTS, INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The MiniLoc™ Safety Infusion Set device is a safety intravascular administration . set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.
- The integral MiniLoc™ Safety Infusion Set safety mechanism is manually . activated during the removal of the MiniLoc™ Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.
- The MiniLoc™ Safety Infusion Set is intended for use in the administration of . fluids and drugs, as well as blood sampling through surgically implanted ports.
- The MiniLoc™ Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
- The MiniLoc™ Safety Infusion Set may be used in any appropriate patient . population.
Device Description
The MiniLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needlestick prevention feature. The MiniLocTM Safety Infusion Set is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling. The MiniLocTM Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only.
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