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510(k) Data Aggregation
K Number
K223891Device Name
Cobra Catheter System
Manufacturer
Date Cleared
2023-02-15
(50 days)
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Endovascular Engineering
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cobra Catheter System is indicated for:
- The non-surgical removal of thrombi and emboli from venous vasculature.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from the venous vasculature.
Device Description
The Cobra Catheter System (Cobra System) is a minimally invasive aspiration catheter with an integrated handle that connects to a commercially available vacuum pump. The aspiration catheter has an expanding funnel at the distal end for clot capture and features radiopaque markers for visibility under fluoroscopic quidance. The funnel resides within the outer sleeve of the aspiration catheter until it is manually deployed in the tarqet vessel using the slider on the handle. The Cobra System can be initially introduced with a 16Fr introducer sheath. The Cobra System allows for navigating to, engagement, ingestion, and transportation of the target obstructive clot out of the peripheral veins to re-establish blood flow from the lower extremities.
The Cobra System is comprised of four (4) components:
Aspiration Catheter: The Aspiration Catheter includes a catheter shaft with a funnel at the distal end an integrated handle that allows for manual control of the device features. The handle features a port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter and for measurement of intravascular pressure using a standard pressure line setup, if needed. The Aspiration Catheter is compatible with standard accessories such as a 0.035" or 0.038" quidewire.
Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter and connects to the proximal end of the handle. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter lumen during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter System during use.
Rotating Hemostasis Valve (RHV): The RHV is an accessory that attaches to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy-Borst valve to enable compatibility with the Dilator as well as sealing on ancillary devices, such as guidewires or diagnostic catheters.
Dilator: An optional accessory to the Cobra System. The Dilator is compatible with 0.035" or 0.038″ guidewires and can be used to facilitate navigation.
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