# K980850: Bard 9FR., 40CC. Rediguard and Taperseal Intra-Aortic Balloons

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 3, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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. 40cc ArmorGlide coated TaperSeal and RediGuard IAB catheters: named in the summary without a submission number

## 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/K980850
Methodology: https://510kreport.com/methodology