FDA device listing
ARROWg+ard Hemodialysis Catheters,Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue…
FDA device listing 1955654461 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | ARROWg+ard Hemodialysis Catheters,Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter,Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter,You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K993933 |
| Product codes | MPB |
| Device names | MPB - Catheter, Hemodialysis, Non-Implanted |
| 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 CR, a.s., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 1000563940, 3006425876, 3015859709 |
| FEI numbers | 1000563940, 3003737899, 3006425876, 3015859709 |
| Establishment operations | Foreign Exporter, Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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