Sarns Membrane Oxygenator W/Integral Reser. #9461
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K896671 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 with Integral Reservoir #9461 is an oxygenator designed for cardiopulmonary bypass, as defined by its device type and classification name. It is a Class II medical device under product code DTZ, intended for use in cardiovascular procedures requiring extracorporeal circulation.
This device was cleared via the FDA 510(k) process under submission K896671, with a substantially equivalent decision issued on February 14, 1990. It is supplied as a single-use device and is not MRI conditional unless explicitly stated; no sterility, size, or storage details are provided in the source data beyond its authorization and classification.
Frequently asked questions
What is the Sarns Membrane Oxygenator with Integral Reservoir #9461 used for?
It is designed for cardiopulmonary bypass during cardiovascular procedures requiring extracorporeal circulation, as defined by its device type and classification name.
Is the Sarns Membrane Oxygenator with Integral Reservoir #9461 reusable or single-use?
It is supplied as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused.
How was the Sarns Membrane Oxygenator with Integral Reservoir #9461 authorized for market?
It was cleared via the FDA 510(k) process under submission K896671, with a substantially equivalent decision issued on February 14, 1990.
What regulatory classification does the Sarns Membrane Oxygenator with Integral Reservoir #9461 have?
It is a Class II medical device under product code DTZ, as determined by its FDA classification and regulatory pathway.
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 Reser. #9461, K896671 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL RE... | FDA 510(k), Sarns Membrane Oxygenator W/integral Reser. #9461… - 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 | K896671 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K896671 24 fields · synced Sep 23, 2026