FDA device listing
IntellaNav StablePoint™ Cable
FDA device listing 1480572401 · Amphenol Alden Products Company
Key facts
| Proprietary names | IntellaNav StablePoint™ Cable |
|---|---|
| Owner/operator | Amphenol Alden Products Company |
| Owner/operator number | 10025614 |
| Product codes | OAD, OAE |
| Device names | OAD - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter, OAE - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OAD, ORCA1.OAE |
| Review panels | Cardiovascular |
| Registered establishments | AMPHENOL ALDEN PRODUCTS COMPANY |
| Establishment registrations | 3007029079, 3012260771 |
| FEI numbers | 3007029079, 3012260771 |
| Establishment operations | Contract Manufacturer |
| 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