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510(k) Data Aggregation
K Number
K130518Device Name
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
Manufacturer
LUTHER NEEDLESAFE PRODUCTS, INC.
Date Cleared
2013-04-30
(62 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
LUTHER NEEDLESAFE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.
Device Description
The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.
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K Number
K040527Device Name
LOW PROFILE LUTHER SAFETY HUBER
Manufacturer
LUTHER NEEDLESAFE PRODUCTS, INC.
Date Cleared
2004-03-26
(25 days)
Product Code
FPA, REQ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LUTHER NEEDLESAFE PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.
Device Description
The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.
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