FDA device listing
NaviCurve Stylet,TipTracker Stylet,VPS Rhythm DLX Device with TipTracker Technology
FDA device listing 1076005463 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | NaviCurve Stylet,TipTracker Stylet,VPS Rhythm DLX Device with TipTracker Technology |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K220363 |
| Product codes | LJS |
| Device names | LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5970 |
| Review panels | General Hospital |
| Registered establishments | Arrow Internacional de Chihuahua S.A. de C.V., Arrow International, LLC (subsidiary of Teleflex Incorporated) |
| Establishment registrations | 9680794, 3015859709 |
| FEI numbers | 3003737899, 3015859709 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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