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510(k) Data Aggregation
K Number
K170881Device Name
ISP Safety Huber Needle Infusion Set
Manufacturer
Infusion Safety Products, Inc.
Date Cleared
2017-12-14
(265 days)
Product Code
PTI, FPA
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Infusion Safety Products, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.
Device Description
The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in various model numbers. The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths: 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc. 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.
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