Advanced Cardiovascular Systems Hemostatic Valves
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K854261 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 Advanced Cardiovascular Systems Hemostatic Valves are classified as adaptors, stopcocks, manifolds, and fittings for cardiopulmonary bypass. These devices are designed to control fluid flow and prevent backflow during cardiovascular procedures, ensuring hemostasis and system integrity in surgical and diagnostic settings.
These valves are intended for use in cardiopulmonary bypass circuits, connecting tubing, catheters, or other medical devices. They are supplied as reusable components and are regulated under FDA classification DTL (870.4290). The device received FDA 510(k) clearance (K854261) in 1985, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Advisory Committee.
Frequently asked questions
Are these hemostatic valves designed for single-use or can they be reused in multiple procedures?
The Advanced Cardiovascular Systems Hemostatic Valves are explicitly labeled as reusable components for cardiopulmonary bypass circuits. They are intended to be cleaned, sterilized, and reused across multiple surgical or diagnostic procedures, ensuring cost efficiency and system integrity over time.
What types of procedures or medical settings are these valves primarily intended for?
These valves are specifically designed for cardiopulmonary bypass circuits, where they control fluid flow and prevent backflow during cardiovascular surgeries or diagnostic procedures. They connect tubing, catheters, or other medical devices to maintain system integrity and hemostasis.
How many different sizes or models of these hemostatic valves are available, and how can I identify them?
The device data lists multiple FEI numbers (e.g., 1000208624, 3003737899, etc.), which correspond to distinct product codes and likely represent different sizes, fittings, or configurations. While exact dimensions or model names aren’t provided, these identifiers help distinguish between variants for tubing compatibility or surgical needs.
What regulatory pathway was followed for FDA clearance of these valves, and what does that mean for their use?
The valves received FDA 510(k) clearance (K854261) in 1985 under the Substantially Equivalent (SESE) determination by the Cardiovascular Advisory Committee. This means the device was deemed comparable to a legally marketed predicate, ensuring compliance with safety and performance standards for use in cardiopulmonary bypass systems.
How should these reusable valves be stored to maintain their integrity between uses?
While specific storage instructions aren’t detailed in the data, reusable medical devices like these typically require clean, dry, and protected environments (e.g., sterile packaging or dedicated storage) to prevent contamination. Follow the manufacturer’s reprocessing protocols—including cleaning, sterilization (e.g., autoclave or chemical sterilization), and inspection—to ensure safe reuse.
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: Advanced Cardiovascular Systems Hemostatic Valves, ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES… - FDA.report, Device Listing 1269826574 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K854261 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Cardiovascular Systems, Inc.
Sources (1)
- FDA 510(k) K854261 24 fields · synced Sep 19, 2026