Search Results
Found 1 results
510(k) Data Aggregation
K Number
K042666Device Name
LUTH-ALL SUB-Q NEEDLE SET
Manufacturer
Date Cleared
2004-12-21
(83 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LUTH-ALL MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It operates as a standard safety needle with the addition of a built in active safety feature which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.
Device Description
The Luth-All Safety Sub-Q Needle Set is a 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. It operates as a standard safety needle with the addition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks. It is supplied sterile for single use only.
Ask a Question
Ask a specific question about this device
Page 1 of 1