CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172305 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 CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are mechanical circulatory support devices classified as Systems, Balloon, Intra-Aortic and Control. These devices assist cardiac function by inflating and deflating a balloon within the aorta to augment coronary perfusion, reduce left ventricular afterload, and improve myocardial oxygenation during critical cardiac events. They are designed for temporary hemodynamic support in patients with acute heart failure, cardiogenic shock, or during high-risk percutaneous interventions.
These devices are intended for single-use and require sterile handling. The CS100/CS100i and CS300 models are regulated under FDA 510(k) clearance (K172305) as substantially equivalent to predicate devices, classified under Device Class II (DSP). They are supplied as part of a complete system, including the balloon catheter, control unit, and associated tubing. Storage and use adhere to manufacturer guidelines for sterile conditions, with no MRI compatibility specified. The devices are distributed by Datascope Corp., Manwah, NJ, USA.
Frequently asked questions
What is the primary purpose of the CS100/CS100i and CS300 Intra-Aortic Balloon Pumps?
These devices are designed to assist cardiac function by inflating and deflating a balloon within the aorta. This action augments coronary perfusion, reduces left ventricular afterload, and improves myocardial oxygenation during critical cardiac events such as acute heart failure, cardiogenic shock, or high-risk percutaneous interventions. The mechanical support helps stabilize the patient’s hemodynamics until recovery or further intervention.
Are the CS100/CS100i and CS300 Intra-Aortic Balloon Pumps intended for single-use or reuse?
The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are explicitly designed for single-use only. This ensures sterility and safety for the patient, as reuse could compromise integrity and introduce contamination risks. Always follow manufacturer guidelines for sterile handling and disposal after a single use.
What components are included in the complete system for the CS100/CS100i and CS300?
The system is supplied as a complete package, including the intra-aortic balloon catheter, the control unit (for inflation/deflation timing), and associated tubing for proper fluid and pressure management. This ensures all necessary components are available for immediate use in critical cardiac scenarios.
How should the CS100/CS100i and CS300 Intra-Aortic Balloon Pumps be stored?
These devices must be stored under sterile conditions as per the manufacturer’s instructions. Proper storage prevents contamination and maintains device integrity. The packaging should remain unopened until use, and any exposed components should be handled with sterile techniques to avoid compromising sterility.
Are there any MRI compatibility considerations for the CS100/CS100i or CS300?
The manufacturer does not specify MRI compatibility for the CS100/CS100i or CS300 Intra-Aortic Balloon Pumps. If MRI imaging is required for the patient, consult the manufacturer’s guidelines or clinical protocols to assess potential risks, as metallic components or electronic controls may interact with magnetic fields.
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: CS100 IABP with IntelliSync - Getinge, CS300 IABP - Getinge, Maquet Datascope CS100 Intra-Aortic Balloon Pump, Datascope cs100 Ballon Pump Service Manual PDF - Scribd, CS100/CS100i Intra-Aortic Balloon Pump, CS300 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 | K172305 | Class II | Active |
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Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K172305 24 fields · synced Oct 1, 2026