FDA device listing
Sniper Infusion Catheter with Ballon Occlusion
FDA device listing 1816901303 · Eurofins - Infinity Laboratory Group Inc.
Key facts
| Proprietary names | Sniper Infusion Catheter with Ballon Occlusion |
|---|---|
| Owner/operator | Eurofins - Infinity Laboratory Group Inc. |
| Owner/operator number | 10080298 |
| Product codes | MJN |
| Device names | MJN - Catheter, Intravascular Occluding, Temporary |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.4450 |
| Review panels | Cardiovascular |
| Registered establishments | Eurofins Infinity Laboratory Group Inc. |
| Establishment registrations | 3013944123 |
| FEI numbers | 3013944123 |
| 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