Cardiosave Hybrid Intra-Aortic Balloon Pump
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151254 FDA 510(k)
- FDA Product Code
- DSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3535 FDA 510(k)
- Regulation Number
- 870.3535 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardiosave Hybrid Intra-Aortic Balloon Pump is a mechanical circulatory support device classified as a System, Balloon, Intra-Aortic and Control. It functions as an assistive therapy for patients with acute heart failure or cardiogenic shock by augmenting cardiac output through timed inflation and deflation of an intra-aortic balloon, improving coronary and systemic perfusion during the cardiac cycle.
This device is supplied as a reusable system and is intended for use in critical care settings, such as intensive care units (ICUs) and cardiac catheterization labs. It operates via an external console connected to an intra-aortic balloon catheter, requiring sterile preparation and proper positioning under clinical supervision. The system is regulated under FDA 510(k) clearance (K151254) and falls under device classification II, adhering to regulatory standards for cardiovascular assist devices. Storage and handling follow manufacturer guidelines to ensure functionality and patient safety.
Frequently asked questions
What is the Cardiosave Hybrid Intra-Aortic Balloon Pump used for?
The Cardiosave Hybrid Intra-Aortic Balloon Pump is designed as an assistive therapy for patients experiencing acute heart failure or cardiogenic shock. It works by improving coronary and systemic perfusion through timed inflation and deflation of an intra-aortic balloon, effectively augmenting cardiac output during the cardiac cycle. This helps relieve the heart’s workload and maintain adequate blood flow to vital organs.
Is the Cardiosave Hybrid Intra-Aortic Balloon Pump a single-use or reusable device?
The Cardiosave Hybrid Intra-Aortic Balloon Pump is supplied as a reusable system. This means it is intended for repeated use in clinical settings, provided it undergoes proper cleaning, disinfection, and maintenance between procedures. Reusability is critical in critical care environments like ICUs and cardiac catheterization labs, where resources must be optimized for patient care.
How is the Cardiosave Hybrid Intra-Aortic Balloon Pump supplied and prepared for use?
The device is supplied as a complete reusable system, including an external console and an intra-aortic balloon catheter. Before use, sterile preparation and proper positioning of the catheter are required under clinical supervision. The system must be handled according to manufacturer guidelines to ensure functionality, sterility, and patient safety during critical procedures.
What regulatory pathway does the Cardiosave Hybrid Intra-Aortic Balloon Pump follow?
The Cardiosave Hybrid Intra-Aortic Balloon Pump is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K151254. It is classified as a Class II device under the FDA’s regulatory framework for cardiovascular assist devices. This classification ensures it meets stringent performance and safety standards for use in high-risk clinical settings.
Where should the Cardiosave Hybrid Intra-Aortic Balloon Pump be stored, and what are the key considerations?
The device must be stored following the manufacturer’s guidelines to maintain functionality and ensure patient safety. Proper storage includes protecting it from physical damage, contamination, and environmental factors like extreme temperatures or humidity. Since it is used in critical care settings, storage should also account for quick access and readiness for emergency deployment, adhering to clinical protocols for mechanical circulatory support devices.
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: Datascope/Getinge Recalls Cardiosave Intra-Aortic Balloon Pumps (IABPs, New recalls announced for troubled heart devices—FDA previously urged ..., Cardiosave Hybrid and Rescue Intra-aortic Pumps Recalled for Shutdown, Maquet CARDIOSAVE HYBRID Operating Instructions Manual, Datascope Corp. recalls Cardiosave Hybrid. Intra-Aortic Balloon Pump ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151254 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K151254 24 fields · synced Oct 1, 2026