# K040801: Intra-Aortic Balloon (Iab)

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: May 6, 2004 after 38 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K892799 (1989). 8 ancestors in all.
9 later devices descend from it; 1 cites it directly.
9 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970689: Iab-04840-U;Iab-04250-U;Iab-04240-U;Iab-04230-U, Arrow Intl., Inc. (1998) Summary page 4.
- K963920: 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,, Arrow Intl., Inc. (1997) Summary page 4.
- K993966: 8FR. Narrowflex Universal Intra-Aortic Balloon Catheter, Arrow Intl., Inc. (2000) Summary page 4.
- K000729: Arrow Ultra 8 Intra-Aortic Balloon Catheters (Iabs) 8FR 30CC and 40CC Universal, Arrow Intl., Inc. (2000) 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 4.

## Most influential descendants
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System (2007), 8 descendants of its own
- K112372: Cardiosave Hybrid Intra-Aortic Balloon Pump (2011), 3 descendants of its own
- K112327: Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories (2011), 2 descendants of its own
- K151254: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (2015), 1 descendant of its own
- K181122: CARDIOSAVE Intra-Aortic Balloon Pump (2018), 0 descendants of its own

## Recalls of this device
- Feb 2, 2009 · Not classified · Z-1216-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1214-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1219-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1221-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1218-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1210-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1215-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1220-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1217-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1211-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1212-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1222-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 
- Feb 2, 2009 · Not classified · Z-1213-2009: A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc 

## Indications for use
The Intra-Aortic Balloon (IAB) 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/K040801
Methodology: https://510kreport.com/methodology