# K200634: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

- Pathway: 510(k) (Special)
- Applicant: Arrow International, Inc.
- Decided: Apr 9, 2020 after 30 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: 4 generations back to K892799 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
5 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190117: Fiberoptix IAB, Arrow International, Inc. (2019) Summary page 4.
- 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 5.

## Recalls of this device
- Apr 29, 2024 · Class I · Z-1878-2024: 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
The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically 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/K200634
Methodology: https://510kreport.com/methodology