# K991783: AB-180 XC System, Model AB-180XC

- Pathway: 510(k) (Traditional)
- Applicant: Cardiacassist, Inc.
- Decided: Nov 1, 2000 after 526 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852698 (1985). 5 ancestors in all.
13 later devices descend from it; 3 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 2.
- K852698: Bio Medicus Bio Pump Model BP-80, Bio Medicus, Inc. (1985) Summary page 2.
- K780953: Model 1861 Blood Pump, Medtronic Vascular (1978) Summary page 2.

## Most influential descendants
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K061369: Tandem Heart Escort (T.H.E.) Controller, Model 5140-8500 (2006), 4 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K110493: Tandemheart Pump (2011), 2 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own

## Indications for use
The AB-180 XC System consists of the AB-180 XC Blood Pump, a singleuse, disposable device; the AB-180 XD Blood Pump Controller, a reusable control system for the AB-180 XC Blood Pump; and disposable accessory items used in conjunction with the AB-180 XC Blood Pump. The extracorporeal circuit is not supplied with the AB-180 XC System. The AB-180 XC Blood Pump is a single use, disposable centrifugal-blood pump designed to circulate blood through an extracorporeal circuit. The AB-180 XC Blood Pump is intended for extracorporeal circulatory support using an extracorporeal-bypass-circuit. Intended duration of use is for periods appropriate to cardiopulmonary bypass, up to six hours. It is also intended to be used as an extracorporeal circulatery support system (for periods up to six hours) for procedures not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, mitral valve reoperation, surgery of the vena cava.and/or.aotta, liver transplant, etc.)

Source page: https://510kreport.com/device/K991783
Methodology: https://510kreport.com/methodology