LBW
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
56 days90th percentile
5clearances measured
FDA profile
- Official device name
- Set, Dialysis, Single Needle (Co-Axial Flow)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Implant
- Adverse events (MAUDE)
- 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DUAL LUMEN NEEDLES (K904433) | Akcess Medical Products, Inc. | 1990-11-23 |
| MODIFIED DUAL LUMEN NEEDLE (K864629) | Quinton, Inc. | 1986-12-16 |
| DUAL LUMEN NEEDLE (PRODUCT CHANGE) (K860515) | Quinton, Inc. | 1986-03-04 |
| COAXIAL DUAL FLOW CATHETER (K820859) | Terumo Medical Corp. | 1982-04-16 |
| HEMOCATH I KIDNEY DIALYSIS CATHETER (K801968) | Medical Components, Inc. | 1980-09-26 |
Track LBW automatically
Every clearance here is in the API, with alerts when new ones post.