# K190101: UltraFlex IAB

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Jun 28, 2019 after 157 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993966 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
2 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993966: 8FR. Narrowflex Universal Intra-Aortic Balloon Catheter, Arrow Intl., Inc. (2000) Summary page 4.

## Recalls of this device
- Apr 29, 2024 · Class I · Z-1879-2024: Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the i

## Indications for use
UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure

Source page: https://510kreport.com/device/K190101
Methodology: https://510kreport.com/methodology