Search Results
Found 1 results
510(k) Data Aggregation
K Number
K954457Device Name
MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
Manufacturer
Date Cleared
1996-05-15
(233 days)
Product Code
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
MEDI-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EDDY™ Intravascular Infusion Catheter is intended for general Intravascular use, including neuro, peripheral, and coronary vasculature. The catheter is intended to be flow tracked in order to access distal tortuous vasculature. Once the subsclective region has been accessed, the catheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications oulined by the manufacturer.
Device Description
The device is a single lumen device which facilitates distal vascular access. The catheter is available in two shaft sizes. The larger shaft size models incorporate a 2.7F proximal shaft with a 2.2F flexible distal shaft and a distal internal diameter of .019". The smaller shaft size models incorporate a 2.4F proximal shaft with a 1.7F flexible distal shaft and a distal internal diamcter of .013". The catheter is available in usable shaft lengths from 135 to 165cm, in 5cm increments.
The catheter is intended to be flow tracked, but may accommodate steerable hydrophilic guidewires of < . 016" for the larger shaft size models. The EDDY™ is available in straight and bulb tip configurations. Radiopaque markers at the distal tip and the mid-shaft bond facilitate fluoroscopic visualization of the device. The proximal end of the infusion catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The distal end of the catherer is steam shapeable as are other flow tracked catheters currently on the market. A white ink proximal mark is located 100cm from the tip of the catheter to indicate when the stylet is to be removed during insertion of the infusion catheter into the guide catheter.
The outer surface of the EDDY™ catheter is coated with a hydrophilic coating system, except for the proximal 30cm of shatt. The device will be provided sterile, and is intended for one procedure use only (disposable).
Ask a Question
Ask a specific question about this device
Page 1 of 1