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510(k) Data Aggregation
K Number
K081940Device Name
AVALON ELITE VASCULAR ACCESS KIT
Manufacturer
AVALON LABORATORIES, LLC
Date Cleared
2008-11-18
(133 days)
Product Code
DRE
Regulation Number
870.1310Why did this record match?
Applicant Name (Manufacturer) :
AVALON LABORATORIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
intended for single use by trained physician to assist in vessel cannulation.
Device Description
Vascular Access Kit - containing dilators, guide wire, scalpel, introducer needle, and syringe.
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K Number
K081820Device Name
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
Manufacturer
AVALON LABORATORIES, LLC
Date Cleared
2008-10-06
(101 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
AVALON LABORATORIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avalon Elite™ Bi-Caval Dual Lumen Catheter is intended for use as a single catheter for both venous drainage and reinfusion of blood via the internal jugular vein during extracorporeal life support procedures.
Device Description
The Avalon Elite™ Bi-Caval Dual Lumen Catheter is a single catheter with two lumens within the cannula body to collect, separate, and return the blood. The product is offered in a range of sizes to address varying patient size requirements. Inlet ports/openings at the distal tip, and proximally, collect blood from the inferior and superior vena cavae and deliver it to the extracorporeal components consisting of at least, a pump and gas exchange device. Blood returns to the patient through the infusion lumen of the cannula where it exits at a port located in the right atrium. The lumens within the cannula body are completely separate throughout their length. This separation is achieved via a thin septum that divides the otherwise circular internal cross section of the main cannula body. The lumens become separate, or split out, at the proximal end of the cannula as is typical of many types of dual lumen cannulae/catheters so that they may be attached by conventional tube fittings. The ratio of the drainage lumen to reinfusion lumen cross sectional area is approximately 2 to 1 deriving from typical pre and post pump pressure/flow characteristics. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre positioned standard guidewire (not supplied.) The device is supplied sterile, non-pryogenic and is intended for single use via prescription.
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K Number
K081933Device Name
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
Manufacturer
AVALON LABORATORIES, LLC
Date Cleared
2008-10-03
(88 days)
Product Code
DWF
Regulation Number
870.4210Why did this record match?
Applicant Name (Manufacturer) :
AVALON LABORATORIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.
Device Description
The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.) The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm]. The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.
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