# K190117: Fiberoptix IAB

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc.
- Decided: Jun 13, 2019 after 140 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K892799 (1989). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840, Arrow Intl., Inc. (2002) Summary page 4.

## Most influential descendants
- K200634: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (2020), 0 descendants of its own

## Indications for use
FIBEROPTIX® IAB with the 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/K190117
Methodology: https://510kreport.com/methodology