9 Fr Percutan Double Lumen Intra-Aortic Balloon
by Kontron Instruments, Inc. 510(k)
Active
510(k) K892798
Overview
The 9 Fr Percutaneous Double Lumen Intra-Aortic Balloon is a cardiovascular device consisting of an inflatable balloon placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies. It is part of a system that includes a control mechanism for regulating the inflation and deflation of the balloon.
This device is supplied as a single-use or reusable product, depending on the specific configuration, and is intended for percutaneous insertion. The 9 Fr size specification indicates its diameter, and it is regulated under FDA 510(k) clearance with product code DSP. The device is classified under System, Balloon, Intra-aortic And Control and is reviewed by the Cardiovascular advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892798 | Date20 Sep 1989 | 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- Withdrawn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 Kontron Instruments, Inc.
Questions
What is the purpose of the 9 Fr Percutaneous Double Lumen Intra-Aortic Balloon?
This device is a cardiovascular product consisting of an inflatable balloon placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies. It is part of a system that includes a control mechanism for regulating balloon inflation and deflation.
Is the 9 Fr Percutaneous Double Lumen Intra-Aortic Balloon single-use or reusable?
The device is supplied as either a single-use or reusable product depending on the specific configuration selected. Both options are available to meet different clinical needs and usage requirements.
What does the 9 Fr specification indicate about this device?
The 9 Fr specification indicates the diameter of the device, which is an important measurement for ensuring proper compatibility with insertion techniques and patient anatomy during percutaneous procedures.
What is the regulatory status of this device?
The device is regulated under FDA 510(k) clearance with product code DSP and is classified under System, Balloon, Intra-Aortic And Control. It was reviewed by the Cardiovascular advisory committee and received a decision of Substantially Equivalent in 1989.