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510(k) Data Aggregation
K Number
K140562Device Name
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
Manufacturer
LEOMED, LLC
Date Cleared
2014-06-16
(103 days)
Product Code
KNY
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
LEOMED, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wijay EZ-Void™ External Catheter Valve is indicated for use, to aid in emptying the urinary bladder, for short-term (7 days or less) in adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device in accordance with its instructions for use, and (2) for whom normal bladder cycling is not contraindicated.
Device Description
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