SARNS INGANT Membrane Oxygenator
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K895393 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 INGANT Membrane Oxygenator is a device classified as an Oxygenator, Cardiopulmonary Bypass. It is designed for use during cardiopulmonary bypass procedures to facilitate gas exchange in the bloodstream.
This device is manufactured by 3M Company and is supplied as a Class II medical device under product code DTZ. It received FDA 510(k) clearance with number K895393 on December 4, 1989, and is regulated under 870.4350.
Frequently asked questions
What is the SARNS INGANT Membrane Oxygenator used for?
The SARNS INGANT Membrane Oxygenator is designed for use during cardiopulmonary bypass procedures to facilitate gas exchange in the bloodstream. It helps maintain oxygenation and carbon dioxide removal during cardiac surgery.
How is the SARNS INGANT Membrane Oxygenator supplied?
The device is manufactured by 3M Company and is supplied as a Class II medical device under product code DTZ. It is designed for single-use in cardiopulmonary bypass procedures.
What is the regulatory status of the SARNS INGANT Membrane Oxygenator?
The device received FDA 510(k) clearance with number K895393 on December 4, 1989, and is regulated under 870.4350. It was determined to be substantially equivalent to predicate devices for cardiovascular use.
Is the SARNS INGANT Membrane Oxygenator reusable or single-use?
The SARNS INGANT Membrane Oxygenator is designed for single-use in cardiopulmonary bypass procedures. It should not be reused or resterilized as this could compromise device performance and patient safety.
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 INGANT MEMBRANE OXYGENATOR (K895393) — FDA 510 (k) | Innolitics, SARNS INGANT MEMBRANE OXYGENATOR (K895393) - FDA 510 (k), SARNS INGANT MEMBRANE OXYGENATOR 510 (k) K895393 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K895393 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K895393 24 fields · synced Sep 26, 2026