Vascumed EZ Y-Connector
510(k) K902741
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902741 | Date1 Nov 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- Withdrawn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
- DTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4290
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Vascumed EZ Y-Connector is classified as an adaptor, stopcock, manifold, and fitting for cardiopulmonary bypass procedures. It is designed to facilitate fluid transfer and connection between medical tubing and devices in cardiovascular applications, ensuring secure and leak-proof junctions during surgical interventions.
This device is intended for single-use in sterile environments, adhering to FDA regulation 870.4290 under product code DTL. Supplied as a reusable or disposable component depending on clinical protocol, it must be handled in accordance with sterile techniques. The device holds an FDA 510(k) clearance (K902741) with a decision date of November 1, 1990, and is categorized under the Cardiovascular specialty. No MRI safety information is specified.
Other devices from Vascumed Systems
Questions
AI-generated answers, 19 Sep 2026
Is the Vascumed EZ Y-Connector designed for reuse in clinical settings, or is it intended for single-use only?
The Vascumed EZ Y-Connector is explicitly designed for single-use in sterile environments, though clinical protocols may dictate whether it is treated as reusable or disposable. The device must always be handled under sterile techniques to ensure safety and efficacy during cardiopulmonary bypass procedures.
What types of surgical procedures is this connector primarily used for, and why is it considered critical in those settings?
The Vascumed EZ Y-Connector is specifically designed for cardiovascular applications, particularly in cardiopulmonary bypass procedures. It facilitates secure, leak-proof fluid transfer and connections between tubing and medical devices, ensuring reliability during high-stakes surgeries where fluid integrity is critical.
Are there different sizes or models available for the Vascumed EZ Y-Connector, and how would a clinician determine the correct fit for their setup?
The device data lists multiple FEI numbers, which correspond to different product variants or configurations (e.g., tubing sizes or connector types) for the Vascumed EZ Y-Connector. While exact sizing details aren’t specified, clinicians should refer to the manufacturer’s documentation or consult Vascumed Systems to select the appropriate model based on their tubing compatibility and procedural requirements.
How should the Vascumed EZ Y-Connector be stored to maintain its sterility and functionality before use?
Since the device is intended for single-use in sterile environments, it should be stored in its original, sealed packaging until ready for use. Proper storage conditions—such as a clean, dry area protected from contamination—are essential to preserve sterility and prevent degradation before deployment in surgical settings.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical practice?
The Vascumed EZ Y-Connector received FDA 510(k) clearance (K902741) under the Traditional pathway, with a decision date of November 1, 1990. This means the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets FDA safety and effectiveness standards for use in cardiovascular procedures, particularly in cardiopulmonary bypass systems.