Disposable Hemostatic Y-Connectors
FDA 510(k)Class II (US FDA 510(k))
by Coeur, Inc.
Identifiers
- 510(k) Number
- K113132 FDA 510(k)
- FDA Product Code
- DTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4290 FDA 510(k)
- Regulation Number
- 870.4290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable Hemostatic Y-Connectors are classified as adaptors, stopcocks, manifolds, and fittings for cardiopulmonary bypass systems. These single-use devices are designed to facilitate fluid transfer while maintaining a secure, hemostatic seal in cardiovascular procedures, preventing leakage during circulation management.
Intended for sterile, single-use applications in controlled medical environments, these connectors are supplied as disposable components for use in cardiopulmonary bypass circuits. They comply with FDA 510(k) clearance under regulation 21 CFR 870.4290 and are categorized under Class II medical devices. No MRI safety information or reusable variants are specified in the regulatory data.
Frequently asked questions
Are these Y-connectors reusable or intended for single-use only in clinical settings?
These Disposable Hemostatic Y-Connectors are explicitly designed for single-use only in sterile medical environments. The manufacturer, Coeur, Inc., emphasizes their role as disposable components within cardiopulmonary bypass circuits, ensuring no risk of contamination or cross-infection between patients. Reuse is not supported or specified in the regulatory data.
What types of cardiovascular procedures are these connectors intended to support?
While the device is classified under adaptors, stopcocks, manifolds, and fittings for cardiopulmonary bypass systems, it is not described as intended for any specific procedure. Instead, it is designed to facilitate fluid transfer and maintain a hemostatic seal during cardiovascular procedures involving cardiopulmonary bypass, such as open-heart surgeries or complex cardiac interventions. The focus is on preventing leakage during circulation management.
How are these Y-connectors supplied, and what should I consider for storage?
The Disposable Hemostatic Y-Connectors are supplied as sterile, single-use components for cardiopulmonary bypass circuits. Since they are disposable, they should be stored in their original packaging in a clean, dry environment to preserve sterility until use. The manufacturer does not specify temperature or humidity requirements, but standard medical device storage practices (e.g., away from direct sunlight, extreme temperatures, or contaminants) should be followed to maintain integrity.
Are there multiple sizes or models available for these Y-connectors?
The regulatory data lists multiple FEI (Final Establishment Identification) numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the device description does not provide explicit details on varying sizes or configurations. For precise sizing or compatibility with specific bypass circuits, it is recommended to consult Coeur, Inc. or refer to their technical documentation, as these connectors may be engineered to fit standard cardiopulmonary bypass system interfaces.
What regulatory pathway was followed for FDA clearance of these Y-connectors?
The Disposable Hemostatic Y-Connectors received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device under regulation 21 CFR 870.4290. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent (SESE) to a predicate device. The clearance number is K113132, and the decision was finalized on January 20, 2012.
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: DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132) — FDA 510 (k) - Innolitics, DISPOSABLE HEMOSTATIC Y-CONNECTORS 510(k) K113132 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113132 | Class II | Active |
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Manufacturer
- Manufacturer
- Coeur, Inc.
Sources (1)
- FDA 510(k) K113132 24 fields · synced Sep 19, 2026