QIR — Pediatric Hemodialysis System Class II
FDA product code QIR covers "Pediatric Hemodialysis System", a Class II medical device regulated under 21 CFR 876.5861. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QIR
- Device Class
- Class II
- Regulation Number
- 876.5861
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180055 | bellco srl (now part of medtronic, inc) | CARPEDIEM System | April 29, 2020 |