Intra-Aortic Balloon-Pump
by Avco Medical Products 510(k)
Active
510(k) K790241
Overview
The Intra-Aortic Balloon-Pump is a mechanical circulatory assist device classified as a balloon pump system for intra-aortic use. It is designed to augment cardiac output by inflating and deflating a balloon within the descending aorta, timed to the cardiac cycle to improve coronary and systemic perfusion during periods of myocardial ischemia or cardiogenic shock.
This device is intended for temporary use in a clinical setting, typically during cardiac surgery or in emergencies such as cardiogenic shock. Supplied as a sterile, single-use system, it requires precise placement via catheterization and connection to an external control unit. Regulated under FDA 510(k) clearance (K790241) and classified as a Class II device (DSP), it adheres to regulatory standards for cardiovascular assist devices, ensuring compliance with safety and performance requirements for intra-aortic interventions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790241 | Date23 Feb 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DSP
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3535
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Avco Medical Products
Questions
What is the Intra-Aortic Balloon-Pump used for?
The Intra-Aortic Balloon-Pump is a mechanical circulatory assist device designed to augment cardiac output by inflating and deflating a balloon within the descending aorta. It improves coronary and systemic perfusion during periods of myocardial ischemia or cardiogenic shock.
How is the Intra-Aortic Balloon-Pump supplied and is it reusable?
The device is supplied as a sterile, single-use system that requires precise placement via catheterization and connection to an external control unit. It is intended for temporary use in clinical settings such as cardiac surgery or emergency situations.
What is the regulatory classification of the Intra-Aortic Balloon-Pump?
The Intra-Aortic Balloon-Pump is regulated under FDA 510(k) clearance (K790241) and classified as a Class II device (DSP). It adheres to regulatory standards for cardiovascular assist devices, ensuring compliance with safety and performance requirements for intra-aortic interventions.
How is the Intra-Aortic Balloon-Pump implanted and operated?
The device requires precise placement via catheterization in the descending aorta. It is connected to an external control unit that times the inflation and deflation of the balloon to the cardiac cycle, optimizing coronary and systemic perfusion during use.