Sarns Membrane Oxygenator W/Integral Cardio Reserv
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K890808 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 Sarns Membrane Oxygenator W/Integral Cardio Reserv is an oxygenator, cardiopulmonary bypass device. It is used in cardiovascular applications. The device is classified as a class 2 device.
The device has FDA 510K clearance with the regulation number 870.4350. It is supplied by 3M Company and has a product code of DTZ. The device was cleared on May 1, 1989, with a decision of Substantially Equivalent.
Frequently asked questions
What is the Sarns Membrane Oxygenator used for?
The Sarns Membrane Oxygenator is used in cardiovascular applications as a cardiopulmonary bypass device, providing oxygenation during medical procedures.
Is the Sarns Membrane Oxygenator a single-use device?
The device data does not specify whether the Sarns Membrane Oxygenator is for single-use or reuse, it is classified as a class 2 device.
What is the regulatory status of the Sarns Membrane Oxygenator?
The Sarns Membrane Oxygenator has FDA 510K clearance with the regulation number 870.4350, and was cleared on May 1, 1989, with a decision of Substantially Equivalent.
Who manufactures the Sarns Membrane Oxygenator?
The Sarns Membrane Oxygenator is supplied by 3M Company.
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: Sarns Membrane Oxygenator W/Integral Cardio Reserv, Sarns Membrane Oxygenator W/integral Cardio Reserv 510 (k) K890808 ..., PDF K890808 - Sarns Membrane Oxygenator W/Integral Cardio Reserv, Sarns Membrane Oxygenator W/Integral Cardio Reserv - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890808 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K890808 24 fields · synced Oct 1, 2026