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510(k) Data Aggregation
K Number
K042234Device Name
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
Manufacturer
SPECIALTY HEALTH PRODUCTS, INC.
Date Cleared
2004-09-08
(21 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SPECIALTY HEALTH PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The LiftLoc® 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 LiftLock Safety Infusion Set safety mechanism is manually . activated during the removal of the LiftLoc® 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 LiftLoc® Safety Infusion Set is intended for use in the administration of . fluids and drugs, or blood sampling through surgically implanted vascular ports.
- The LiftLoc Safety Infusion Set will be marketed as a sterile, non-pyrogenic, . single use device.
- The LiftLoc® Safety Infusion Set may be used in any appropriate patient ● population.
Device Description
The LiftLoc® Safety Infusion Set is a non-coring Huber needle and administration set with an integral safety needlestick prevention feature. The LiftLoc® 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 LiftLoc® Safety Infusion Set is supplied sterile and non-pyrogenic, for single use only. The product has two configurations: one with an adaptable Y-injection site and one without. A Patient Comfort Pad is also available as an optional accessory.
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