FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VitalFlow Console
K Number: K230364
·
Decision Aug 25, 2023
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
7
Applicant Total
2
Review Days
196
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Basic Information
- Device Name
- VitalFlow Console
- K Number
- K230364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
- Date Received
- February 10, 2023
- Decision Date
- August 25, 2023
- Product Code
- QNR
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QNR), ordered by most recent decision date.
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VitalFlowTM Centrifugal Pump
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CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
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LifeSPARC System
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·Cardiovascular
Other Clearances by Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
| K Number | Device Name | ||
|---|---|---|---|
| K223898 | VitalFlowTM Centrifugal Pump | Aug 25, 2023 | Substantially Equivalent |