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510(k) Data Aggregation
K Number
K053429Device Name
ADVANCED UROLOGICAL CATHETERManufacturer
Date Cleared
2006-02-08
(61 days)
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Advanced Urological Catheter is used to pass fluids to or from the urinary tract.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter for the "Advanced Urological Catheter" by EntraCare LLC. It details the regulatory approval process but does not contain information regarding
acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific study-related details requested.
Therefore, I cannot provide the requested information from the given text.
The document primarily focuses on:
- The product name and applicant.
- The regulatory classification and product codes.
- Confirmation of substantial equivalence to a legally marketed predicate device.
- General regulatory requirements the manufacturer must adhere to.
- The intended use of the device: "The Advanced Urological Catheter is used to pass fluids to or from the urinary tract."
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