(233 days)
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Not Found
No
The description focuses on the physical characteristics and intended use of a catheter for infusion, with no mention of AI or ML capabilities.
No
The device is described as an infusion catheter used to deliver diagnostic, embolic, or therapeutic materials, but it is not itself a therapeutic device.
No
The device is an infusion catheter intended for delivering diagnostic, embolic, or therapeutic materials; it is not a diagnostic device itself.
No
The device description clearly details a physical catheter with various components, materials, and dimensions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The EDDY™ Intravascular Infusion Catheter is a device inserted into blood vessels for accessing distal vasculature and delivering diagnostic, embolic, or therapeutic materials directly into the body. It is an invasive device used for direct intervention and delivery, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states it's for "general Intravascular use" and for the "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels." This describes a procedure performed within the patient's body.
Therefore, the EDDY™ Intravascular Infusion Catheter falls under the category of an invasive medical device used for therapeutic and diagnostic procedures performed in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Pursuant to Section 12, Safe Medical Devices Act of 1990) EDDY™ Intravascular Infusion Catheter
1 . The trade or proprietary name of the device is Medi-tech EDDY™ Intravascular Infusion Catherer. The common or usual name is Continuous Flush Catheter.
The EDDY™ Intravascular Infusion Catheter is intended for general 2. 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.
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