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Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.

Maximum recommended indwelling time is not more than 30 days.

Prescription Use ONLY (Part 21 CFR 801 Subpart D)

Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.

This document is a 510(k) summary for a medical device (Coude Foley catheter / or Tiemann Foley catheter). It primarily focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

Therefore, the provided text does not contain information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies as requested in the prompt.

The document states the "Indications for Use" for the device, which is "for routine drainage of the urinary bladder" with a "Maximum recommended indwelling time is not more than 30 days." However, these are indications, not performance metrics or acceptance criteria.

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a detailed technical specification for the device.

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