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510(k) Data Aggregation
K Number
K974775Device Name
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
Manufacturer
AIRTRONIC SERVICES, INC.
Date Cleared
1998-02-19
(59 days)
Product Code
FAP
Regulation Number
876.1620Why did this record match?
Applicant Name (Manufacturer) :
AIRTRONIC SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The pressure sensor is for use in the long term weekly monitoring of full serial bladder (vesical) pressure in patients that perform regular clean intermittent catheterizations (CIC). Regular once per week long term monitoring of bladder pressure in patients at risk for developing high bladder pressures and urinary incontinence associated with, urinary tract infections (UTI), vesicoureteral reflux and renal insufficiency. The most significant source of urologic morbidity and mortality in patients with spinal conditions where CIC is used is renal failure secondary to upper tract deterioration from high bladder pressures.
Cystometry (CMG) is an integral part in the urologic evaluation of patients prior to the use of this device. At no time is this device to be used in place of CMGs for diagnostics. Patients with CMG leak point pressures greater than 40 cm H20 are at significant risk for upper tract deterioration. The frequency and timing of CMG urodynamic studies in patients with spinal injuries continues to be controversial, but use of this device may insure that full CMGs or other suitable diagnostics are performed on a timely basis by the patients attending physician.
Device Description
Single Channel Urological Pressure Gauge
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