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510(k) Data Aggregation
K Number
K052952Device Name
CATHASSIST
Manufacturer
Date Cleared
2006-05-14
(206 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
PHYSICIAN TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CathAssist™ Female Urinary Catheter Insertion Accessory is used to assist routine adult female urethral catheterization in both hospital and office settings. Some of the clinical situations in which female catheterization is indicated include:
1. Major surgery;
2. Urinary retention;
3. Collection of a sterile "cath" urine specimen;
4. Bladder irrigation; and
5. Labor and Delivery.
The CathAssist™ Female Urinary Catheter Insertion Accessory is intended for use by:
1. Nurses and caregivers in the rapid and easy insertion of a female urinary catheter;
2. By adult females who are required to perform intermittent self catheterization following surgery; and
3. By adult females required to self-catheterize and who have motor or visual disabilities.
Device Description
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