CDI H/S Cuvette, Modification
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K915265 FDA 510(k)
- FDA Product Code
- DRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4330 FDA 510(k)
- Regulation Number
- 870.4330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CDI H/S Cuvette, Modification is a disposable blood-gas monitoring device designed for use in cardiopulmonary bypass systems. It is classified as an online blood-gas monitor and is intended for continuous measurement of arterial blood gases during surgical procedures requiring extracorporeal circulation, such as open-heart surgery. The device facilitates real-time analysis of oxygen and carbon dioxide levels, enabling precise hemodynamic management during critical interventions.
This cuvette is supplied as a single-use, dry device (product code DRY) and is regulated under FDA 510(k) clearance (K915265), granted in 1992. It is intended for integration into cardiopulmonary bypass circuits and must be handled in accordance with sterile medical device protocols. The device is classified as Class II under FDA regulations (870.4330), adhering to special controls for blood-gas monitoring systems. Storage and usage must comply with manufacturer guidelines to ensure accuracy and safety in clinical settings.
Frequently asked questions
What is the CDI H/S Cuvette, Modification used for?
The CDI H/S Cuvette, Modification is a disposable device designed specifically for online blood-gas monitoring during cardiopulmonary bypass procedures. It enables continuous measurement of oxygen (pO₂) and carbon dioxide (pCO₂) levels in arterial blood, which is critical for maintaining stable hemodynamic conditions during surgeries like open-heart procedures. By providing real-time data, it helps clinicians adjust ventilation and perfusion parameters dynamically to optimize patient outcomes.
How is the CDI H/S Cuvette supplied, and is it reusable?
The CDI H/S Cuvette is supplied as a single-use, dry device (product code DRY). It is not intended for reuse, as repeated use could compromise sterility, accuracy, and safety. Each cuvette is sterile and designed for one-time integration into a cardiopulmonary bypass circuit, adhering to standard sterile medical device protocols to prevent contamination and ensure reliable performance.
What regulatory pathway does the CDI H/S Cuvette follow?
The CDI H/S Cuvette, Modification is regulated under the FDA’s 510(k) clearance pathway, specifically granted under clearance number K915265 in 1992. It is classified as a Class II device under FDA regulation 870.4330, which applies special controls for blood-gas monitoring systems. This classification ensures it meets stringent performance and safety standards for use in critical cardiopulmonary applications.
How should the CDI H/S Cuvette be stored before use?
The CDI H/S Cuvette must be stored in accordance with the manufacturer’s guidelines to preserve sterility and functionality. As a single-use, dry device, it should be kept in its original packaging until immediately before integration into the cardiopulmonary bypass circuit. Exposure to moisture, extreme temperatures, or contamination could compromise its performance, so proper handling and storage are essential to maintain accuracy and reliability during surgical procedures.
Can this cuvette be used with any cardiopulmonary bypass system?
The CDI H/S Cuvette is specifically designed for integration into cardiopulmonary bypass systems and must be compatible with the system’s specifications. While it is intended for general use in such systems, compatibility depends on the system’s design and the manufacturer’s instructions. Clinicians should verify that the cuvette’s dimensions and connection interfaces align with their bypass circuit to ensure proper functionality and avoid leaks or operational issues during surgery.
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: CDI (TM) H/S CUVETTE, MODIFICATION - fda.innolitics.com, K915265 - CDI (TM) H/S CUVETTE | FDA 510 (k) | 3M Company, CDI (TM) H/S CUVETTE, MODIFICATION - fda.report, Device Listing 1412237249 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K915265 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K915265 24 fields · synced Oct 1, 2026