Paragon Adult Maxi PMP Oxygenator with Tubing Pack
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201642 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 with Tubing Pack is a Cardiopulmonary Bypass Oxygenator, designed for use in extracorporeal circulation during cardiac and vascular surgical procedures. It facilitates gas exchange by oxygenating and decarboxylating blood outside the body, supporting temporary circulatory function while the heart is temporarily stopped or bypassed.
This device is supplied as a single-use, sterile system and is intended for 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 (510(k) clearance) and adheres to the Medical Devices Directive (MDD). The tubing pack is included for seamless integration with the oxygenator, ensuring compatibility with standard cardiopulmonary bypass circuits. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What types of surgical procedures is the Paragon Adult Maxi PMP Oxygenator designed to support during extracorporeal circulation?
The Paragon Adult Maxi PMP Oxygenator is specifically designed for use in cardiac and vascular surgical procedures where extracorporeal circulation is required. This includes scenarios where the heart is temporarily stopped or bypassed, such as during open-heart surgeries, valve replacements, or complex vascular repairs. Its role is to oxygenate and decarboxylate blood outside the body, maintaining temporary circulatory function.
Is the Paragon Adult Maxi PMP Oxygenator intended for reuse, or is it meant to be used only once?
The Paragon Adult Maxi PMP Oxygenator is supplied as a single-use device. This design ensures patient safety and sterility, as it is intended for controlled clinical environments like operating rooms or cardiac catheterization labs, where sterile protocols must be strictly followed. Reuse is not recommended or supported.
What does the tubing pack included with the oxygenator provide, and is it compatible with standard cardiopulmonary bypass circuits?
The tubing pack included with the Paragon Adult Maxi PMP Oxygenator is designed for seamless integration with the oxygenator, ensuring a complete and compatible system for extracorporeal circulation. It is engineered to work with standard cardiopulmonary bypass circuits, simplifying setup and reducing the risk of incompatibility issues during surgery.
How should the Paragon Adult Maxi PMP Oxygenator be stored, and what sterility guarantees does it offer?
The device is supplied as a sterile system, meaning it is pre-sterilized and packaged to maintain sterility until use. Storage must comply with standard sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, away from contamination, and following manufacturer guidelines to prevent compromise of sterility before deployment in clinical settings.
What regulatory pathways has the Paragon Adult Maxi PMP Oxygenator followed, and which governing bodies have authorized its use?
The device has undergone regulatory review through the FDA’s 510(k) clearance process, classified as a Class II medical device, and adheres to the Medical Devices Directive (MDD) in Europe. These pathways confirm its substantial equivalence to predicate devices and compliance with safety and performance standards for use in extracorporeal circulation during cardiac and vascular procedures.
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 | K201642 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chalice Medical Ltd
- FDA Applicant
- Chalice Medical , Ltd.
Sources (2)
- FDA 510(k) K201642 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026