# K962177: Bard Taperseal Intra-Aortic Balloon Catheter & Introducer Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 4, 1996 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) Sheathless 40cc Pre-Wrapped Double-Lumen 9.0 F. Intra-Aortic Balloon Catheter (Model 1AB-04240S): 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/K962177
Methodology: https://510kreport.com/methodology