FDA device listing
Emerge PTCA Dilatation Catheter,Emerge Push PTCA Dilatation Catheter,Gateway PTA Dilatation Catheter,NC Emerge PTCA…
FDA device listing 1141721378 · Boston Scientific Corporation
Key facts
| Proprietary names | Emerge PTCA Dilatation Catheter,Emerge Push PTCA Dilatation Catheter,Gateway PTA Dilatation Catheter,NC Emerge PTCA Dilatation Catheter |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| 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 | Boston Scientific Corp., Marina Bay Cust. Fulfillment Center, Boston Scientific Corporation, BOSTON SCIENTIFIC CORPORATION |
| Establishment registrations | 1225687, 2134265, 1000121056 |
| FEI numbers | 1000121056, 3001451463, 3002095335 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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