FDA device listing
Inter Semi-Compliant PTCA Balloon Dilatation Catheter
FDA device listing 2006606348 · Gamamed Vascular Systems Inc.
Key facts
| Proprietary names | Inter Semi-Compliant PTCA Balloon Dilatation Catheter |
|---|---|
| Owner/operator | Gamamed Vascular Systems Inc. |
| Owner/operator number | 10092344 |
| Premarket submissions | K123473 |
| 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 | GAMAMED VASCULAR SYSTEMS INC. |
| Establishment registrations | 3035111606 |
| FEI numbers | 3035111606 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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