Acumen Assisted Fluid Management (AFM) Software Feature
FDA 510(k) clearance K233984 · decided 2024-08-02
Clearance details
- K-number
- K233984
- Device name
- Acumen Assisted Fluid Management (AFM) Software Feature
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-12-18
- Decision date
- 2024-08-02
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- QMS
- Device class
- 2
- Regulation number
- 870.5600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, 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 |
|---|---|---|
| Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029) | Edwards Lifesciences | 2020-11-13 |
Recalls involving this device
No recalls on record reference this clearance.