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510(k) Data Aggregation

    K Number
    K200419
    Device Name
    Kalera Vacuum Aspiration Catheter (K-VAC)
    Date Cleared
    2020-05-22

    (92 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kalera Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.
    Device Description
    K-VAC is a sterile, single-use aspiration-irrigation catheter that is designed to assist in the removal of stone fragments during standard ureteroscopy. K-VAC is a dual-lumen catheter with two concentric lumens. The outer lumen is the irrigation lumen that accommodates delivery of irrigation/contrast solution. The larger, inner lumen is the aspiration lumen through which the stone fragments are removed. The inner diameter of the aspiration lumen is 2.5 mm. The distal 5 cm of the K-VAC tip is soft with a steering mechanism on the catheter handle and embedded wires to actuate the tip. In this way, stones and debris in the renal calyces can be fluidized with irrigation and aspirated. An additional component to the device is a radiopaque introducer, which is 0.035" and 0.038" guidewire compatible. The tip of the introducer has a soft tapered tip. The design of K-VAC allows the trained operator to maneuver and position K-VAC via a standard 12/14F ureteral access sheath under fluoroscopic guidance, followed by controlled irrigation and aspiration of stones and debris from the renal pelvis and calyces. K-VAC is composed of well-characterized biocompatible materials commonly used in urinary catheters. The catheter is mechanical and contains no electrical components.
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