PEH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemodialysis Catheter Luer End Cap
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- For use in hemodialysis catheters to reduce hub infection.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ClearGuard HD Antimicrobial Barrier Cap (K180111) | Pursuit Vascular, Inc. | 2018-05-25 |
| CLEARGUARD HD END CAP (K131060) | Pursuit Vascular, Inc. | 2013-12-16 |
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