Paragon Adult Maxi PMP Oxygenator (Model XCMOP405PMP)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191246 FDA 510(k)
- FDA Product Code
- DTZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4350 FDA 510(k)
- Regulation Number
- 870.4350 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Paragon Adult Maxi PMP Oxygenator (Model XCMOP405PMP) is a cardiopulmonary bypass oxygenator designed for adult cardiac procedures. It facilitates gas exchange during extracorporeal circulation by oxygenating and decarboxylating blood, supporting cardiac surgery and other high-risk interventions requiring temporary circulatory assistance.
This device is supplied sterile and intended for single-use in controlled clinical environments such as operating rooms or cardiac catheterization labs. It is classified as a Class II medical device under FDA regulations (21 CFR 870.4350) and has received FDA 510(k) clearance as well as MDD compliance. The oxygenator is non-magnetic and compatible with MRI environments when used as directed, though specific MRI safety instructions must be followed. Storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What types of adult cardiac procedures is the Paragon Adult Maxi PMP Oxygenator designed to support during extracorporeal circulation?
The Paragon Adult Maxi PMP Oxygenator (Model XCMOP405PMP) is specifically designed for adult cardiac procedures requiring temporary circulatory assistance. It facilitates gas exchange by oxygenating and decarboxylating blood during cardiopulmonary bypass, making it suitable for high-risk interventions such as complex cardiac surgeries where stable extracorporeal circulation is critical.
Is this device intended for reuse, or is it meant to be used only once per patient?
This device is explicitly intended for single-use only. It is supplied sterile and designed for controlled clinical environments like operating rooms or cardiac catheterization labs, ensuring patient safety and compliance with medical device standards.
How should the Paragon Adult Maxi PMP Oxygenator be stored to maintain its sterility and functionality?
The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions—such as avoiding contamination, extreme temperatures, or prolonged exposure to light—are essential to ensure it remains effective when used in clinical settings.
Can this oxygenator be used in an MRI environment, and are there any specific safety instructions to follow?
Yes, the Paragon Adult Maxi PMP Oxygenator is non-magnetic and compatible with MRI environments when used as directed. However, it is critical to follow the manufacturer’s specific MRI safety instructions to ensure safe operation and avoid any potential risks during imaging procedures.
What regulatory pathways has this device undergone, and what classification does it hold under FDA regulations?
The Paragon Adult Maxi PMP Oxygenator has received FDA 510(k) clearance and is classified as a Class II medical device under FDA regulations (21 CFR 870.4350). It was determined to be substantially equivalent to a predicate device through a traditional 510(k) review process by the Cardiovascular (CV) Advisory Committee. Additionally, it complies with the Medical Devices Directive (MDD).
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191246 | Class II | Active |
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Manufacturer
- Manufacturer
- Chalice Medical Ltd
- FDA Applicant
- Chalice Medical , Ltd.
Sources (2)
- FDA 510(k) K191246 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026