Bio-Medicus Tubing Connectors
510(k) K883956
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883956 | Date28 Oct 1988 | 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- Withdrawn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
- DTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4290
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bio-Medicus Tubing Connectors are classified as adaptors, stopcocks, manifolds, and fittings for cardiopulmonary bypass systems. These connectors facilitate secure and leak-proof connections between tubing and medical devices in cardiovascular procedures, ensuring reliable fluid flow during extracorporeal circulation or bypass operations. Designed for compatibility with cardiopulmonary bypass circuits, they help maintain system integrity and reduce the risk of air embolism or contamination.
These connectors are supplied as single-use disposable devices, intended for use in sterile operating room environments during cardiac surgeries or extracorporeal life support procedures. They are regulated under FDA regulation 870.4290 and granted a 510(k) clearance (K883956) as substantially equivalent to predicate devices. Available in multiple sizes and configurations, they are packaged sterile and must be discarded after a single use to prevent cross-contamination. No MRI safety information is specified.
Other devices from Bio Medicus, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Bio-Medicus Tubing Connectors used for?
These connectors are designed specifically for cardiopulmonary bypass (CPB) systems, facilitating secure and leak-proof connections between tubing and medical devices during cardiovascular procedures. They ensure reliable fluid flow during extracorporeal circulation or bypass operations, helping maintain system integrity and reducing risks like air embolism or contamination.
Are the Bio-Medicus Tubing Connectors sterile and single-use?
Yes, the connectors are packaged sterile and intended for single-use only. This design prevents cross-contamination and ensures patient safety by avoiding reuse, which could compromise sterility or introduce pathogens.
What sizes and configurations are available for the Bio-Medicus Tubing Connectors?
The connectors come in multiple sizes and configurations to accommodate various cardiopulmonary bypass circuit setups. While exact dimensions vary by model, they are designed for compatibility with standard CPB tubing systems. Refer to the product catalog or specifications sheet for detailed size options.
How should the Bio-Medicus Tubing Connectors be stored?
The connectors must be stored in their original, sealed packaging to maintain sterility. Keep them in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, use immediately in a sterile operating room environment.
Can the Bio-Medicus Tubing Connectors be reused?
No, these connectors are explicitly designed for single-use only. Reusing them violates manufacturer guidelines and could compromise patient safety by introducing contamination or compromising system integrity. Discard after use in accordance with medical waste protocols.