FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Custodiol HTK Solution
K Number: K192408
·
Decision Apr 24, 2020
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
18
Applicant Total
5
Review Days
233
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Basic Information
- Device Name
- Custodiol HTK Solution
- K Number
- K192408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dr. Franz Kohler Chemie GmbH
- Date Received
- September 4, 2019
- Decision Date
- April 24, 2020
- Product Code
- KDL
- 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 |
|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | FDA class 2 | Gastroenterology, Urology |
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