# K963920: 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Jun 17, 1997 after 260 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: 1 generation back to K892799 (1989). 2 ancestors in all.
19 later devices descend from it; 2 cite it directly.
10 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960713: 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9FR.Sheath), Arrow Intl., Inc. (1996) Summary page 1.
- K892799: 8 FR Percutan Double Lumen Intra-Aortic Balloon, Kontron Instruments, Inc. (1989) Summary page 1.

## 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

## Indications for use
Refractory left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.

Source page: https://510kreport.com/device/K963920
Methodology: https://510kreport.com/methodology