VitalFlow Set with Balance Biosurface
FDA 510(k) clearance K240880 · decided 2024-09-12
Clearance details
- K-number
- K240880
- Device name
- VitalFlow Set with Balance Biosurface
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-01
- Decision date
- 2024-09-12
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- QJZ
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, 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 |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
| Novalung System (K191407) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 |
Recalls involving this device
No recalls on record reference this clearance.
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| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
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| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |