Cardiopulmonary Support (CPS) System
510(k) K892664
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892664 | Date13 Feb 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DTZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4350
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Cardiopulmonary Support (CPS) System is a Cardiopulmonary Bypass Oxygenator, designed to temporarily replace or assist the heart and lungs during surgical procedures. It facilitates the exchange of oxygen and carbon dioxide in the blood, maintaining systemic circulation and oxygenation when the patient’s natural cardiopulmonary function is compromised or temporarily suspended. This device is integral to open-heart surgeries and other complex cardiovascular interventions where direct perfusion support is required.
The system is supplied as a Class II medical device with FDA 510(k) clearance (K892664) under regulation 870.4350, classified under the DTZ product code. It is intended for single-use in controlled surgical environments, such as operating rooms, and requires sterile packaging. Compatibility with MRI safety standards is not specified in the regulatory data. Storage and handling must adhere to manufacturer guidelines to ensure sterility and functionality prior to use.
Other devices from Bard Cardiosurgery Div
Questions
AI-generated answers, 1 Oct 2026
What is the Bard CPS Cardiopulmonary Support (CPS) System used for?
The Bard CPS System is designed as a cardiopulmonary bypass oxygenator to temporarily replace or assist the heart and lungs during surgical procedures. It facilitates oxygen exchange and maintains systemic circulation when a patient’s natural cardiopulmonary function is compromised, making it essential for open-heart surgeries and other complex cardiovascular interventions.
Is the Bard CPS System intended for single-use or reuse?
The Bard CPS System is explicitly intended for single-use in controlled surgical environments, such as operating rooms. This ensures sterility and functionality are maintained for each procedure, reducing the risk of contamination or cross-infection.
How is the Bard CPS System supplied and what are its sterility requirements?
The Bard CPS System is supplied in sterile packaging, which is critical for maintaining its integrity before use. The device must be handled according to manufacturer guidelines to preserve sterility and ensure proper functionality during surgery.
What regulatory approval does the Bard CPS System hold?
The Bard CPS System holds FDA 510(k) clearance (K892664) under regulation 870.4350, classified under the DTZ product code. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a Class II medical device.
Are there different models or sizes available for the Bard CPS System?
The provided data lists multiple registration numbers (e.g., 3030125051, 3021599320) associated with the Bard CPS System, which may correspond to different models or configurations. These variations are likely tailored to accommodate varying patient sizes or surgical requirements, though specific details on sizing or model distinctions would require consulting the manufacturer’s documentation.