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Sign in to claim this brandPulsion Medical Systems AG
US
Last updated May 23, 2026
What Pulsion Medical Systems AG makes
Pulsion Medical Systems AG manufactures thermodilution catheters and related accessories for hemodynamic monitoring, including the PulsioCath line. It also produces the PICCO-2 and PICCO Plus systems (Model 8500 and 8100), which incorporate optical and thermal sensors for continuous cardiac output and vascular function assessment. Disposable optical probes and CEVox optical modules are part of the portfolio, as are monitoring kits with injectate sensors and temperature housings.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in critical care and intraoperative monitoring settings. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Pulsion Medical Systems AG manufacture?
Pulsion Medical Systems AG specializes in devices for hemodynamic monitoring, particularly thermodilution catheters and related accessories like the PulsioCath line. It also produces systems such as the PICCO-2 (Model 8500) and PICCO Plus (Model 8100), which combine optical and thermal sensors for continuous cardiac output and vascular function assessment. The company’s portfolio further includes disposable optical probes, CEVox optical modules, and monitoring kits with injectate sensors and temperature housings, all designed for critical care and intraoperative use.
Where is Pulsion Medical Systems AG based?
Pulsion Medical Systems AG is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.
Which regulatory registries or databases list Pulsion Medical Systems AG’s devices?
Pulsion Medical Systems AG’s devices are listed in the FDA’s 510(k) clearance registry. This classification indicates that the devices have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with U.S. regulatory requirements for Class II medical devices.
How are Pulsion Medical Systems AG’s devices classified under FDA regulations?
Pulsion Medical Systems AG’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as hemodynamic monitoring systems like thermodilution catheters and continuous cardiac output devices. The 510(k) clearance process is used to demonstrate compliance with these controls.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PiCCO Catheter | PV2014L08-A | FDA UDI | Class II | Active |
| PiCCO Module | PC4510 | FDA UDI | Class II | Active |
| PiCCO Monitoring Kit | PV8103 | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2014L16N | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2015L20-A | FDA UDI | Class II | Active |
| PiCCO Catheter | PV2013L07-A | FDA UDI | Class II | Active |
| PiCCO Monitoring Kit | PV8115CVP | FDA UDI | Class II | Unknown |
| PiCCO Monitoring Kit | PV8115 | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2014L22N | FDA UDI | Class II | Unknown |
| Injectate temperature sensor housing | PV4046 | FDA UDI | Class II | Active |
| PiCCO Catheter | PV2014L08N | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2014L16-A | FDA UDI | Class II | Active |
| PulsioFlex | PC4000 | FDA UDI | Class II | Active |
| PiCCO Catheter | PV2013L07N | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2015L20N | FDA UDI | Class II | Unknown |
| PiCCO Catheter | PV2014L22-A | FDA UDI | Class II | Active |
| Pulsion Pulsiocath Thermodilution Catheters & Accessories | K072364 | FDA 510(k) | Class II | Active |
| Pulsion Picco-2, Model 8500 | K072735 | FDA 510(k) | Class II | Active |
| Pulsion Picco2 (8500), Cevox Optical Module (pc3015), Cevox Disposable Probes (pv2022-30 Thru -38, Pv2022-46 Thru -48) | K091786 | FDA 510(k) | Class II | Active |
| Pulsioflex | K112448 | FDA 510(k) | Class II | Active |
| Pulsion Picco Plus, Model 8100 | K060898 | FDA 510(k) | Class II | Active |
| Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion In-Line Injectate Sensor | K991886 | FDA 510(k) | Class II | Active |
| Pulsion Continuous Pulse Contour Cardiac Output (picco) System | K001762 | FDA 510(k) | Class II | Active |
| Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing Pv 4046 | K020587 | FDA 510(k) | Class II | Active |
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