FDA device listing
Blazer Open-Irrigated Ablation Catheter,Cable, IntellaNav Ablation Catheter,Cable, IntellaTip MiFi OI,Cable IntellaTip…
FDA device listing 1846987198 · Boston Scientific Corporation
Key facts
| Proprietary names | Blazer Open-Irrigated Ablation Catheter,Cable, IntellaNav Ablation Catheter,Cable, IntellaTip MiFi OI,Cable IntellaTip MiFi OI to Maestro 4000,Cable, Maestro 4000,INTELLAGEN Catheter Adapter Cable 0.3 Meter,INTELLAGEN ECG Connection Cable 3 Meter,INTELLAGEN Foot Pedal,INTELLAGEN Foot Pedal Extension Cable 7 Meter,INTELLAGEN Grounding Cable 3 Meter,INTELLAGEN Irrigation Pump Connection Cable 10… |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Premarket submissions | P150005 |
| 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 | Boston Scientific Corporation, BOSTON SCIENTIFIC CORPORATION, Boston Scientific Limited |
| Establishment registrations | 2124215, 9681260, 1000121056, 3004859241, 3010705768 |
| FEI numbers | 2124215, 1000121056, 3002806565, 3004859241, 3010705768 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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