FDA device listing
LifeStent 5F Vascular Stent System,Lifestent and Lifestent XL Vascular Stent System,Lifestent and Lifestent XL Vascular…
FDA device listing 1404589030 · Sotera Health LLC
Key facts
| Proprietary names | LifeStent 5F Vascular Stent System,Lifestent and Lifestent XL Vascular Stent System,Lifestent and Lifestent XL Vascular Stent System and lifestent solo vascular stent system,LifeStent Solo Vascular Stent System |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NIP |
| Device names | NIP - Stent, Superficial Femoral Artery |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.NIP |
| Review panels | Cardiovascular |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Germany GmbH |
| Establishment registrations | 3002807090, 3005941719 |
| FEI numbers | 3002807111, 3006003617 |
| Establishment operations | Contract Sterilizer |
| 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