FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Diacap Pro Dialyzer
K Number: K170574
·
Decision Aug 11, 2017
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
5
Review Days
165
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Basic Information
- Device Name
- Diacap Pro Dialyzer
- K Number
- K170574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B. Braun Avitum AG
- Date Received
- February 27, 2017
- Decision Date
- August 11, 2017
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by B. Braun Avitum AG
| K Number | Device Name | ||
|---|---|---|---|
| K143482 | xevonta dialyzer | Mar 1, 2016 | Substantially Equivalent |
| K102194 | SOLCART B | Apr 25, 2011 | Substantially Equivalent |
| K100334 | DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 | Apr 22, 2010 | Substantially Equivalent |
| K083460 | DIALOG WITH ADIMEA OPTION | Feb 18, 2010 | Substantially Equivalent |