LivaNova Stockert SCP Centrifugal Pump System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

LIVANOVA SINGAPORE PTE LTD

Class:

Class C medical device

Manufactured by:

LivaNova Deutschland GmbH

Therapeutic area:

Cardiovascular

Therapeutic indications:

The Stockert Centrifugal Pump (SCP) system is intended for use as a centrifugal pump during cardiovascular bypass for typical durations of six hours or less. The system has been developed for operation with the Stockert heart-lung machines and/or the SCPC System. The SCP System consists of the pump control panel, the drive unit, the flow probe and the Cobe(R) Revolution CBP. The system will be used or incorporated with the tubing clamp, emergency unit and SCP.The SCP has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Product summary:

Models: SCP System , complete - 60-00-00, SCP driv unit - 60-01-00, Pump control panel - 60-02-15, Mast holder for pump control panel - 60-02-13, 24V Connection cable for the HLM - 45-11-02, Flow probe (type H9XL) - 96-414-110, Flow probe (alternative: type H9XSB) - 96-414-110, Emergency drive unit(complete) - 60-01-50, COBE Revolution CBP - 96-490-501

Authorization date:

2005-04-21