Oxygenator, Long Term Support Greater Than 6 Hours
The Oxygenator, Long Term Support Greater Than 6 Hours is a device used during prolonged extracorporeal circulation to transfer oxygen into and remove carbon dioxide from the patient's blood outside the body for periods exceeding six hours, as in extended cardiopulmonary bypass or extracorporeal membrane oxygenation (ECMO). It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYS, regulated under 21 CFR 870.4100 in the Cardiovascular specialty. This device is designated as life-sustaining or life-supporting.
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Basic Information
- Product Code
- BYS
- Device Class
- FDA class 2
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232767 | Nautilus VF ECMO Oxygenator | Oct 04, 2023 | Substantially Equivalent | Mc3, Inc. |
| K191935 | Nautilus Smart ECMO Module | Apr 09, 2020 | Substantially Equivalent | Mc3 Incorporated |
| K770720 | TUBING PACK, EXTRACORPOREAL, H-3000 | Aug 04, 1977 | Substantially Equivalent | William Harvey Life Products Corp. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.