FDA device listing
AHDC AGB CURVED KIT,AHDC AGB KIT,AHDC AGB U-BEND KIT,AHDC KIT,Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis…
FDA device listing 1903142083 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | AHDC AGB CURVED KIT,AHDC AGB KIT,AHDC AGB U-BEND KIT,AHDC KIT,Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set,Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set,Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set,Cannon Hemodialysis Catheter,Cannon II Plus; Edge,Cannon II Plus Replacement Hub Set,Catheter Hemodialysis,HEMODIALYSIS KIT,HEMODIALYSIS… |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Product codes | PPO |
| Device names | PPO - Multi-Lumen Hemodialysis Catheterization Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5540 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International C.R. a.s., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3006425876, 3015859709 |
| FEI numbers | 3003737899, 3006425876, 3015859709 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database