LLB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Blood, Extracorporeal And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1993: 2 · 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS (K991005) | Dayspring Medical, Inc. | 1999-06-22 | + Add |
| BLOOD MONITOR BMM 10-4 (K831404) | Gambro, Inc. | 1984-04-25 | + Add |
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