Search Results
Found 3 results
510(k) Data Aggregation
K Number
K984627Device Name
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
Manufacturer
ARTERIAL VASCULAR ENGINEERING, INC.
Date Cleared
1999-07-27
(209 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
ARTERIAL VASCULAR ENGINEERING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.
Device Description
The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.
Ask a Question
K Number
K983927Device Name
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
Manufacturer
ARTERIAL VASCULAR ENGINEERING, INC.
Date Cleared
1999-03-11
(126 days)
Product Code
DQT
Regulation Number
870.1370Why did this record match?
Applicant Name (Manufacturer) :
ARTERIAL VASCULAR ENGINEERING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AVE guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Device Description
The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.
Ask a Question
K Number
K971295Device Name
AVE BRIDGE STENT SYSTEM
Manufacturer
ARTERIAL VASCULAR ENGINEERING, INC.
Date Cleared
1997-11-05
(212 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
ARTERIAL VASCULAR ENGINEERING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.
Device Description
The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.
Ask a Question
Page 1 of 1