pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
FDA 510(k) clearance K233950 · decided 2024-05-10
Clearance details
- K-number
- K233950
- Device name
- pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-12-14
- Decision date
- 2024-05-10
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- KPO
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, recall (Z-2321-2026) | Fresenius Medical Care Holdings, Inc. | 2026-06-05 |