RiteCath Intermittent Urinary Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142575 FDA 510(k)
- FDA Product Code
- EZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5130 FDA 510(k)
- Regulation Number
- 876.5130 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The RiteCath Intermittent Urinary Catheter is a straight urinary catheter designed for intermittent bladder drainage. It is intended for use in adult and pediatric patients, including neonates, infants, children, and adolescents, of both genders. Constructed from biocompatible PVC, this device facilitates temporary urine evacuation while minimizing trauma to the urethral lining. Its design supports safe and effective catheterization procedures in clinical settings.
This catheter is supplied as a single-use, sterile device and is classified under FDA product code EZD within Class II medical devices. It is intended for use in urological and gastroenterological settings, adhering to standard aseptic techniques. The device is cleared through the FDA’s Traditional 510(k) pathway, with a clearance number of K142575. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality, ensuring safe clinical application.
Frequently asked questions
What is the Bard RiteCath Intermittent Urinary Catheter used for?
The Bard RiteCath Intermittent Urinary Catheter is designed specifically for temporary bladder drainage in both adult and pediatric patients, including neonates, infants, children, and adolescents. Its straight design facilitates safe and effective intermittent catheterization while reducing urethral trauma, making it suitable for clinical settings where aseptic techniques are required.
Is the Bard RiteCath catheter single-use or reusable?
The Bard RiteCath Intermittent Urinary Catheter is intended for single-use only. This design ensures sterility and reduces the risk of infection, which is critical for proper catheterization procedures. Reusing the device violates manufacturer guidelines and compromises patient safety.
What materials is the catheter made from, and why does it matter?
The catheter is constructed from biocompatible PVC (polyvinyl chloride), a material chosen for its durability, flexibility, and compatibility with human tissues. This ensures minimal irritation to the urethral lining during insertion and removal, reducing the risk of trauma or infection. The biocompatibility of PVC also aligns with FDA standards for medical devices.
How should the Bard RiteCath catheter be stored to maintain sterility?
The catheter must be stored in its original, unopened packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Follow the manufacturer’s guidelines for shelf life and storage conditions to ensure functionality and safety before use.
What regulatory pathway was used for FDA clearance of this device?
The Bard RiteCath Intermittent Urinary Catheter was cleared through the FDA’s Traditional 510(k) pathway, with a clearance number of K142575. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. The product falls under FDA product code EZD and is classified as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bard RiteCath Intermittent Urinary Catheter (K142575) — FDA 510(k ..., K142575 FDA 510 (k) - Bard RiteCath Intermittent Urinary Catheter, PDF K142575 - Bard RiteCath Intermittent Urinary Catheter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142575 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K142575 24 fields · synced Oct 1, 2026