Panels › Gastroenterology, Urology › Product code LBW · Class 2
Set, Dialysis, Single Needle (Co-Axial Flow)
Regulation 876.5540
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LBW
| Company | 510(k)s | Recalls |
|---|---|---|
| Quinton, Inc. | 2 | 0 |
| Akcess Medical Products, Inc. | 1 | 0 |
| Medical Components, Inc. | 1 | 0 |
| Terumo Medical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 1990 | K904433 | DUAL LUMEN NEEDLES Akcess Medical Products, Inc. | LBW |
| Dec 16, 1986 | K864629 | MODIFIED DUAL LUMEN NEEDLE Quinton, Inc. | LBW |
| Mar 4, 1986 | K860515 | DUAL LUMEN NEEDLE (PRODUCT CHANGE) Quinton, Inc. | LBW |
| Apr 16, 1982 | K820859 | COAXIAL DUAL FLOW CATHETER Terumo Medical Corp. | LBW |
| Sep 26, 1980 | K801968 | HEMOCATH I KIDNEY DIALYSIS CATHETER Medical Components, Inc. | LBW |
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