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510(k) Data Aggregation
K Number
K180738Device Name
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
Manufacturer
Date Cleared
2018-06-14
(84 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Compactcath, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CompactCath TM Lubricated Intermittent Urinary Catheter and OneCath TM Intermittent Urinary Catheter are 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™ and OneCath™ Intermittent Urinary Catheter are sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Both catheters will be offered in multiple French sizes (8 – 18 Fr.), lengths (10" and 16"), two tip designs (straight and coudé).
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