Intra-aortic Balloon Pump Catheter - Modification
by Kontron Instruments, Inc. 510(k)
Active
510(k) K923603
Overview
An intra-aortic balloon pump catheter is a device used for mechanical circulatory support in patients with cardiac conditions. It consists of an inflatable balloon placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies.
This device is supplied as a prescription device and is used in arterial approaches for hemodynamic support. It received FDA 510(k) clearance under K923603 and is classified under product code DYB with advisory committee review in cardiovascular (CV).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK923603 | Date8 Mar 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent