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510(k) Data Aggregation
K Number
K970669Device Name
AEROQUIP SAFESTART IV CATHETER
Manufacturer
Date Cleared
1997-08-01
(158 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
AEROQUIP MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aeroquip SafeStart™ IV Catheter is a sterile, non-pyrogenic, disposable peripheral vascular access catheter intended to provide peripheral venous access per CDC guidelines without the spillage of blood when accessing a vein or artery. It is intended to allow administration of drug and fluids into patients via a standard luer connection. The Aeroquip SafeStart™ IV Catheter permits for any type of intravenous fluid administration (continuous and intermittent) or withdrawal of fluids.
Device Description
The Aeroquip SafeStart™ IV Catheter device is a sterile, non-pyrogenic, disposable, peripheral vascular access catheter. The catheter check valve assembly consists of a catheter tube, a twoway internal check valve, a catheter body and a luer lock interface cap.
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K Number
K970644Device Name
AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM
Manufacturer
Date Cleared
1997-07-31
(161 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
AEROQUIP MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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