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510(k) Data Aggregation
K Number
K160858Device Name
CompactCath Intermittent Urinary Catheter
Manufacturer
COMPACTCATH INC.
Date Cleared
2016-04-26
(28 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
COMPACTCATH INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CompactCath is indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
Device Description
The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
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