Pulsion Medical Systems SE - FDA 510(k) Cleared Devices

Pulsion Medical Systems SE, is now part of Getinge and specializes in cardiovascular monitoring and hemodynamic measurement systems. The company operates with a manufacturing facility in Westbrook, US.

Pulsion Medical Systems received 4 FDA 510(k) clearances from 4 total submissions, with all submissions focused on cardiovascular devices. The company's regulatory clearances span from 2012 to 2020. Notable cleared devices include the PulsioFlex Monitoring System with ProAQT Sensor and the PiCCO Catheter, which represent core technologies in hemodynamic monitoring.

The company is inactive in the FDA 510(k) database, with no new clearances recorded in more than five years. This profile serves as a historical regulatory record of the company's FDA submissions and cleared devices.

Explore the complete list of device names, product codes, and clearance dates in the full regulatory record.

Regulatory submissions have been managed by Getinge and Maquet Cardiovascular.