FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SherpaPak Pediatric Liver Transport System
K Number: K201048
·
Decision Jul 2, 2020
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
42
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- SherpaPak Pediatric Liver Transport System
- K Number
- K201048
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Paragonix Technologies
- Date Received
- April 21, 2020
- Decision Date
- July 2, 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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Other Clearances by Paragonix Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K234060 | KIDNEYvault Portable Renal Perfusion System | Oct 23, 2024 | Substantially Equivalent |
| K223874 | BAROguard | Aug 15, 2023 | Substantially Equivalent |
| K191440 | Paragonix SherpaPak Pancreas Transport System | Dec 20, 2019 | Substantially Equivalent |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Oct 19, 2018 | Substantially Equivalent |