FDA device listing
Zilver 518 Vascular Self-Expanding Stent,Zilver 518® Vascular Stent,Zilver 635 Vascular Self-Expanding Stent,Zilver 635®…
FDA device listing 1576438382 · COOK MEDICAL
Key facts
| Proprietary names | Zilver 518 Vascular Self-Expanding Stent,Zilver 518® Vascular Stent,Zilver 635 Vascular Self-Expanding Stent,Zilver 635® Vascular Stent |
|---|---|
| Owner/operator | COOK MEDICAL |
| Owner/operator number | 9090900 |
| Premarket submissions | P050017 |
| Product codes | NIO, NIP |
| Device names | NIO - Stent, Iliac, NIP - Stent, Superficial Femoral Artery |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NIO, ORCA1.NIP |
| Review panels | Cardiovascular |
| Registered establishments | COOK MEDICAL LLC |
| Establishment registrations | 3005580113 |
| FEI numbers | 3005580113 |
| Establishment operations | Complaint File Establishment |
| 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