# K172305: CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Oct 12, 2017 after 73 days
- Product code: DSP (System, Balloon, Intra-Aortic And Control)
- Device class: 2
- Regulation: 21 CFR 870.3535
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K892222 (1990). 63 ancestors in all.
No later device cites it as a predicate yet.
8 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031636: CS100 Intra-Aortic Balloon Pump, Model 0998-00-3013-XX, Datascope Corp. (2003) Summary page 4.
- K063525: Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump Control System, Datascope Corp. (2007) Summary page 4.

## Recalls of this device
- Jan 23, 2026 · Class II · Z-1486-2026: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
- Jan 23, 2026 · Class II · Z-1487-2026: The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

## Indications for use
The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

Source page: https://510kreport.com/device/K172305
Methodology: https://510kreport.com/methodology