FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Purema H Hemoconcentrator - Pediatric
K Number: K243920
·
Decision Sep 19, 2025
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
1
Review Days
273
Basic Information
- Device Name
- Purema H Hemoconcentrator - Pediatric
- K Number
- K243920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medica USA, Inc.
- Date Received
- December 20, 2024
- Decision Date
- September 19, 2025
- 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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