Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020587 FDA 510(k)
- FDA Product Code
- KRB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1915 FDA 510(k)
- Regulation Number
- 870.1915 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 is a thermodilution probe designed for hemodynamic monitoring. It incorporates an injectate sensor and temperature housing to facilitate accurate measurement of cardiac output, intravascular volume, and systemic vascular resistance through thermal dilution techniques.
This device is intended for single-use in critical care settings, including intensive care units and operating rooms, where real-time hemodynamic assessment is required. Supplied sterile and non-MRI compatible, it is regulated under FDA 510(k) clearance (K020587) and MDR compliance. The temperature housing (PV 4046) integrates with the Pulsiocath catheter system for precise thermal measurements, ensuring compatibility with the PiCCO monitoring platform.
Frequently asked questions
What clinical scenarios is the Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 primarily used for?
This device is designed for hemodynamic monitoring in critical care settings, such as intensive care units (ICUs) and operating rooms, where real-time assessment of cardiac output, intravascular volume, and systemic vascular resistance is essential. It uses thermal dilution techniques to provide precise measurements, making it ideal for patients requiring close cardiovascular monitoring during high-risk procedures or critical conditions.
Is the PV 4046 temperature housing compatible with other monitoring platforms besides the PiCCO system?
The PV 4046 temperature housing is specifically integrated with the Pulsiocath catheter system and is intended for use exclusively with the PiCCO monitoring platform. While it is designed for compatibility within this system, it is not meant to function with other hemodynamic monitoring platforms.
How should the PV 4046 temperature housing be stored, and is it reusable?
The PV 4046 is supplied sterile and is intended for single-use only, meaning it should not be reused after a single procedure. Storage instructions are not explicitly detailed in the provided data, but as a sterile, single-use device, it should be kept in its original packaging until use and discarded after use in accordance with standard medical device disposal protocols.
What regulatory pathways does this device follow, and how does that affect its use?
The PV 4046 is regulated under both FDA 510(k) clearance (K020587) and MDR compliance, indicating it has undergone review by the FDA and meets European medical device regulations. This means it is legally authorized for use in the U.S. and EU markets, but clinicians should confirm local compliance requirements before implementation, particularly regarding single-use protocols and sterile handling.
Can this device be used in MRI environments, and what safety considerations should be noted?
The PV 4046 is explicitly labeled as non-MRI compatible, meaning it should not be used in magnetic resonance imaging environments. Clinicians must ensure the device is not exposed to MRI fields, as this could compromise its functionality or pose safety risks to the patient.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature ..., Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature ..., Injectate temperature sensor housing PV4046… - FDA.report, Injectate temperature sensor housing - BEUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K020587 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulsion Medical Systems AG
Sources (2)
- FDA 510(k) K020587 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026