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510(k) Data Aggregation
K Number
K964154Device Name
SEGUE INFUSION CATHETER
Manufacturer
INTERVENTIONAL INNOVATIONS CORP.
Date Cleared
1997-01-14
(90 days)
Product Code
KRA
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
INTERVENTIONAL INNOVATIONS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Segue Infusion Catheter is indicated for the delivery of solutions into the peripheral and coronary vasculature.
Device Description
The Segue Infusion Catheter is a single lumen, over-the-wire designed to locally deliver solutions into the peripheral and coronary vasculature.
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K Number
K955525Device Name
FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
Manufacturer
INTERVENTIONAL INNOVATIONS CORP.
Date Cleared
1996-08-08
(248 days)
Product Code
KRA
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
INTERVENTIONAL INNOVATIONS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flower™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.
Device Description
The Flower™ Infusion Catheter is a multi-lumen, over-the-wire device designed to locally deliver fluids into the peripheral vasculature.
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