# K083111: Impella 5.0 Catheter Family

- Pathway: 510(k) (Traditional)
- Applicant: Abiomed, Inc.
- Decided: Apr 16, 2009 after 177 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K845045 (1985). 25 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 29 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.
- K032632: Remote Access Perfusion Cannula Left Axillary 21 French, Estech, Inc. (2003) Summary page 1.
- K990573: Estech Arterial Remote Access Perfusion Cannula, Estech, Inc. (1999) Summary page 1.
- K060101: Estech Aortic Easy Flow Cannula, Endoscopic Technologies, Inc. (2006) Summary page 1.
- K943934: Aortic Arch Cannulas, Sorin Group Italia S.R.L. (1995) Summary page 1.
- K913176: Delphin II Centrifugal System, 3M Health Care, Sarns (1991) Summary page 1.

## Most influential descendants
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own

## Recalls of this device
- Jul 5, 2010 · Not classified · Z-2382-2010: Pump may separate at the motor housing while device is explanted

## Indications for use
The IMPELLA 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The IMPELLA 5.0 Catheters also provide pressure measurements which are useful in determining intravascular pressure.

Source page: https://510kreport.com/device/K083111
Methodology: https://510kreport.com/methodology