Nautilus VF ECMO Oxygenator
FDA 510(k) clearance K232767 · decided 2023-10-04
Clearance details
- K-number
- K232767
- Device name
- Nautilus VF ECMO Oxygenator
- Applicant
- Mc3, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-11
- Decision date
- 2023-10-04
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- BYS
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dexter, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nautilus Smart ECMO Module (K191935) | Mc3 Incorporated | 2020-04-09 |
| TUBING PACK, EXTRACORPOREAL, H-3000 (K770720) | William Harvey Life Products Corp. | 1977-08-04 |
Recalls involving this device
No recalls on record reference this clearance.