510(k) DEN180055
DEN180055 is an FDA 510(k) premarket notification submitted by Bellco Srl (Now Part of Medtronic, Inc) for the device "CARPEDIEM System". The FDA issued a decision of De Novo Granted on April 29, 2020. The device falls under product code QIR (Pediatric Hemodialysis System), a Class II device regulated under 21 CFR 876.5861.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 29, 2020
- Date Received
- October 9, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pediatric Hemodialysis System
- Device Class
- Class II
- Regulation Number
- 876.5861
- Review Panel
- GU
- Submission Type
For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.