Nautilus VF ECMO Oxygenator
by Mc3, Inc.
510(k) K232767
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232767 | Date4 Oct 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BYS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4100
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Nautilus VF ECMO Oxygenator 58110 is a diffusion polymethylpentene (PMP) membrane oxygenator designed for extracorporeal life support (ECMO). It facilitates gas exchange by oxygenating and decarboxylating blood outside the body, supporting patients with severe cardiovascular or respiratory failure requiring prolonged extracorporeal circulation. Its membrane-based design enables efficient oxygen transfer while minimizing hemolysis and maintaining blood compatibility. The device is categorized under Oxygenator, Long Term Support Greater Than 6 Hours and is intended for use in critical care settings where extended extracorporeal support is required.
This device is supplied as a single-use, sterile component for integration into an ECMO circuit. The circular flow-path design enhances long-term gas transfer performance, contributing to durability and reliability during extended use. The Nautilus VF ECMO Oxygenator 58110 is MRI-safe and adheres to regulatory standards as indicated by its FDA 510(k) clearance (K232767) under the Cardiovascular advisory committee. Proper storage requires adherence to manufacturer guidelines to preserve sterility and functionality, ensuring readiness for immediate clinical deployment when needed.
Other devices from Mc3, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Nautilus VF ECMO Oxygenator 58110 designed for?
The Nautilus VF ECMO Oxygenator 58110 is specifically designed for extracorporeal life support (ECMO) in patients with severe cardiovascular or respiratory failure requiring prolonged extracorporeal circulation. Its membrane-based diffusion technology facilitates efficient oxygen transfer and decarboxylation of blood outside the body, supporting extended critical care needs. The device’s circular flow-path design enhances durability and reliability during long-term use, making it ideal for scenarios where traditional support methods are insufficient.
How is the Nautilus VF ECMO Oxygenator 58110 supplied, and is it sterile?
The Nautilus VF ECMO Oxygenator 58110 is supplied as a single-use, sterile component. This ensures immediate readiness for clinical deployment without the need for additional sterilization or preparation. The sterile packaging adheres to manufacturer guidelines to maintain functionality and safety, allowing healthcare providers to integrate it directly into an ECMO circuit when required.
Is this device reusable, or is it intended for single-use only?
The Nautilus VF ECMO Oxygenator 58110 is explicitly designed for single-use only. This design choice aligns with clinical best practices for ECMO circuits, reducing the risk of contamination, cross-infection, and device degradation over repeated use. Single-use components also simplify inventory management and ensure consistent performance for each patient.
What storage requirements must be followed to maintain sterility and functionality?
To preserve sterility and functionality, the Nautilus VF ECMO Oxygenator 58110 must be stored according to the manufacturer’s guidelines. This typically includes keeping the device in its original, unopened packaging in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures the device remains ready for immediate use when needed in critical care settings.
Is the Nautilus VF ECMO Oxygenator 58110 MRI-safe, and how does this benefit patients?
Yes, the Nautilus VF ECMO Oxygenator 58110 is MRI-safe, meaning it can be used in patients who require concurrent magnetic resonance imaging (MRI) scans. This feature is particularly beneficial in complex cases where patients may need both prolonged ECMO support and detailed imaging for diagnostic or monitoring purposes. The MRI-safe designation reduces the need for device removal or modification, minimizing disruption to the patient’s care.