# K993966: 8FR. Narrowflex Universal Intra-Aortic Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Feb 18, 2000 after 87 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
12 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Arrow 8Fr. NarrowFlex Universal Intra-Aortic Balloon Catheter Kit: named in the summary without a submission number

## Most influential descendants
- K021462: Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models Iab-05830-F,IAB5840 (2002), 18 descendants of its own
- K060309: Autocat Intra-Aortic Balloon Pump Series (2006), 14 descendants of its own
- K040801: Intra-Aortic Balloon (Iab) (2004), 9 descendants of its own
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K162820: AC3 Series IABP System (2017), 4 descendants of its own

## Recalls of this device
- Apr 29, 2024 · Class I · Z-1880-2024: 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 8Fr. Narrowflex Universal Intra-Aortic Balloon Catheter is clinically indicated for the following conditions: a. Acute Coronary Syndrome b. Cardiac and Non-Cardiac Surgery c. Complications of Heart Failure

Source page: https://510kreport.com/device/K993966
Methodology: https://510kreport.com/methodology