Panels › Gastroenterology, Urology › Product code PEH · Class 2
Hemodialysis Catheter Luer End Cap
Regulation 876.5540
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PEH
| Company | 510(k)s | Recalls |
|---|---|---|
| Pursuit Vascular, Inc. | 2 | 0 |
| Transonic Systems Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Transonic Systems Inc Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40
The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be us Terminated |
PEH | K021571 |
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