FKD
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Canister, Coil
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1992: 1 · 1994: 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 |
|---|---|---|---|
| COIL DIALYSIS, MODELS DM-360 AND DM-360- (K790382) | Estracorporeal, Inc. | 1979-05-02 | + Add |
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