# K112892: Impella 2.5 Plus Catheter

- Pathway: 510(k) (Special)
- Applicant: Abiomed, Inc.
- Decided: Sep 6, 2012 after 342 days
- Product code: PBL
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K852698 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System, Abiomed, Inc. (2008) Summary page 1.

## Indications for use
The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

Source page: https://510kreport.com/device/K112892
Methodology: https://510kreport.com/methodology