FDA device listing
FLASH Flex™ Aorto-Ostial Angioplasty System
FDA device listing 1345011428 · Eurofins - Infinity Laboratory Group Inc.
Key facts
| Proprietary names | FLASH Flex™ Aorto-Ostial Angioplasty System |
|---|---|
| Owner/operator | Eurofins - Infinity Laboratory Group Inc. |
| Owner/operator number | 10080298 |
| Product codes | LOX |
| Device names | LOX - Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.5100 |
| 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