FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SherpaPak Lung Preservation System , SherpaPak Liver Transport System
K Number: K192869
·
Decision Jan 16, 2020
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
40
Applicant Total
1
Review Days
101
Basic Information
- Device Name
- SherpaPak Lung Preservation System , SherpaPak Liver Transport System
- K Number
- K192869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Pragonix Technologies
- Date Received
- October 7, 2019
- Decision Date
- January 16, 2020
- 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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