FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hemafuse System
K Number: K210862
·
Decision Jul 29, 2021
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
194
Applicant Total
1
Review Days
128
Basic Information
- Device Name
- Hemafuse System
- K Number
- K210862
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sisu Global Health
- Date Received
- March 23, 2021
- Decision Date
- July 29, 2021
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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