10.5 French Percutaneous Double Lumen Intra-Aortic

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K882274 ↗

FDA Product Code

DSP

Device Class

Class II

Regulation

21 CFR Part 870.3535

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Kontron Instruments, Inc. →

• What is the 10.5 French Percutaneous Double Lumen Intra-Aortic Balloon System used for?

  This device is intended for cardiovascular support as a percutaneous intra-aortic balloon system with a double lumen design, providing temporary mechanical circulatory assistance in clinical settings where hemodynamic stabilization is required.

• How is the 10.5 French Percutaneous Double Lumen Intra-Aortic Balloon System supplied and is it reusable?

  The device is supplied as a single-use system, meaning it is intended for one patient only and must be discarded after use; reuse is not permitted due to risks of contamination, material degradation, and compromised performance.

• What regulatory pathway was used to clear the 10.5 French Percutaneous Double Lumen Intra-Aortic Balloon System?

  The device was cleared through the FDA 510(k) process under submission K882274, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as Class II under product code DSP with special controls per regulation 870.3535.