# K981660: Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 16, 1998 after 158 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
11 of 20 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) 9Fr. 30cc ArmorGlide coated TaperSeal and RediGuard IAB catheters: named in the summary without a submission number
- (no number) DataScope IAB catheters for sheathless insertion: 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
- Feb 10, 2016 · Class I · Z-1061-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
- Feb 10, 2016 · Class I · Z-1063-2016: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

## Indications for use
Refractory left ventricular failure, Cardiogenic or septic shock, Unstable refractory angina, Impending infarction, Ischemia related ventricular arrhythmias, Weaning from cardiopulmonary bypass, Support and stabilization during coronary angioplasty, Intraoperative pulsatile flow generation, Associated mechanical complications of acute myocardial infarction, Support and stabilization of high-risk patients undergoing general surgical procedures.

Source page: https://510kreport.com/device/K981660
Methodology: https://510kreport.com/methodology