Identifiers
- 510(k) Number
- K912655 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 Minimax Oxygenation System is an oxygenator designed for cardiopulmonary bypass. It is classified as a Class II medical device under FDA regulation 870.4350 and has received FDA 510(k) clearance (K912655) as substantially equivalent to a predicate device.
The system is supplied by Medtronic Vascular and is intended for use in cardiovascular procedures requiring extracorporeal oxygenation and carbon dioxide removal. It is not described as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are included in the device data.
Frequently asked questions
What is the Minimax Oxygenation System used for?
The Minimax Oxygenation System is designed for cardiopulmonary bypass and is intended for use in cardiovascular procedures requiring extracorporeal oxygenation and carbon dioxide removal, as stated in the device description.
How is the Minimax Oxygenation System supplied?
The system is supplied by Medtronic Vascular, as indicated in the manufacturer and applicant fields of the device data.
Is the Minimax Oxygenation System sterile, single-use, or reusable?
The device data does not describe the Minimax Oxygenation System as sterile, single-use, or reusable, so no conclusion can be drawn about its sterility or reusability from the provided information.
What regulatory clearance does the Minimax Oxygenation System have?
The Minimax Oxygenation System has received FDA 510(k) clearance (K912655) as substantially equivalent to a predicate device, as explicitly stated in the authorizations and decision description fields.
Are there any size or model specifications for the Minimax Oxygenation System?
No size specifications, model numbers, or reference numbers are included in the provided device data beyond the name 'Minimax Oxygenation System'.
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: MINIMAX OXYGENATION SYSTEM (K912655) - FDA 510 (k), Medtronic MINIMAX PLUS Oxygenator System - myHealthbox, Medtronic Minimax Plus 3381, CB3381, Minimax 1316 ... - manualzz, Minimax Plus Hollow Fiber Oxygenator - Medtronic Vascular | FDA ..., Minimax Plus Hollow Fiber Oxygenator (with Or Without Medtronic/carmeda ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K912655 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K912655 24 fields · synced Oct 6, 2026