FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
KIDNEY ASSIST-transport
K Number: K211333
·
Decision Jan 20, 2022
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
42
Applicant Total
3
Review Days
262
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Basic Information
- Device Name
- KIDNEY ASSIST-transport
- K Number
- K211333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xvivo Perfusion AB
- Date Received
- May 3, 2021
- Decision Date
- January 20, 2022
- Product Code
- KDN
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KDN | System, Perfusion, Kidney | FDA class 2 | Gastroenterology, Urology |
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