Vacuum Relief Valve (K760894)
by Delta Medical Industries 510(k)
Active
510(k) K760894
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760894 | Date9 Dec 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Vacuum Relief Valve
- 510(k) Number
- FDA Product Code
- DWD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4430
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Suction Control, Intracardiac, Cardiopulmonary Bypass valve, classified under FDA product code DWD and regulation 870.4430. It functions as a safety mechanism to regulate and relieve vacuum pressure in cardiovascular systems, preventing tank or vessel rupture during cardiopulmonary bypass procedures. Designed for critical applications in cardiovascular surgery, it ensures stable pressure control within medical equipment.
The Vacuum Relief Valve (K760894) is intended for use in controlled medical environments, such as operating rooms or cardiac catheterization labs, where precise pressure management is required. Supplied as a reusable component, it adheres to FDA 510(k) clearance (K760894) and is categorized under Device Class II. No specific sterility or MRI safety information is provided in the regulatory data, though standard medical device cleaning protocols apply. Storage should follow manufacturer guidelines to maintain functionality.
Other devices from Delta Medical Industries
Questions
AI-generated answers, 1 Oct 2026
What is the Vacuum Relief Valve K760894 used for?
The Delta Medical Vacuum Relief Valve (K760894) is designed as a suction control mechanism for intracardiac use during cardiopulmonary bypass procedures. Its primary function is to regulate and relieve vacuum pressure in cardiovascular systems, preventing equipment failure—such as tank or vessel rupture—by maintaining stable pressure levels in critical surgical environments like operating rooms or cardiac catheterization labs.
Is the Vacuum Relief Valve K760894 single-use or reusable?
This valve is supplied as a reusable component. It is intended for repeated use in controlled medical settings, provided standard medical device cleaning protocols are followed to ensure functionality and safety between procedures. No specific sterility requirements are noted in the regulatory data.
What regulatory approval does the Vacuum Relief Valve K760894 hold?
The valve holds FDA 510(k) clearance under the reference number K760894, classified as Device Class II. It was determined substantially equivalent to a predicate device through a traditional review process by the FDA’s Cardiovascular Advisory Committee. This clearance allows its use in regulated medical environments for the specified purpose.
Where should the Vacuum Relief Valve K760894 be stored?
Storage instructions are not detailed in the regulatory data, but it is recommended to follow the manufacturer’s guidelines to preserve functionality. Since it is reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation or contamination before and after use.
Does the Vacuum Relief Valve K760894 have any special handling requirements?
While no specific sterility or MRI safety information is provided, standard medical device cleaning protocols should be adhered to for reuse. The valve operates in cardiovascular systems, so proper maintenance—such as avoiding cross-contamination—is critical to ensure reliable performance during high-pressure surgical procedures. Always refer to Delta Medical’s operational manual for detailed handling instructions.