FDA device listing
INSYTE INTRODUCER CATHETER
FDA device listing 1597372826 · Arrow International LLC (subsidiary of Teleflex Incorporated
Key facts
| Proprietary names | INSYTE INTRODUCER CATHETER |
|---|---|
| Owner/operator | Arrow International LLC (subsidiary of Teleflex Incorporated |
| Owner/operator number | 2518433 |
| Premarket submissions | K942045 |
| Product codes | FOZ |
| Device names | FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | Arrow International C.R. a.s. |
| Establishment registrations | 3006425876 |
| FEI numbers | 3006425876 |
| Establishment operations | Foreign Exporter, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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