# P170038: CentriMag Circulatory Support System

- Pathway: PMA
- Applicant: Abbott
- Decided: Dec 6, 2019 after 742 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 22, 2024 · Class II · Z-2215-2024: Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console ma

Source page: https://510kreport.com/device/P170038
Methodology: https://510kreport.com/methodology