# K961509: Intra-Aortic Balloon Pump System 97 Modified

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Nov 15, 1996 after 210 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.
18 later devices descend from it; 1 cites it directly.
8 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K002256: Arrow Acat 2 Intra-Aortic Balloon Pump (2001), 17 descendants of its own
- K060309: Autocat Intra-Aortic Balloon Pump Series (2006), 14 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
- K192238: AC3 Series Intra-Aortic Balloon Pump (IABP) (2019), 3 descendants of its own

Source page: https://510kreport.com/device/K961509
Methodology: https://510kreport.com/methodology