FDA device listing
Blazer II XP Temperature Ablation Catheter,Blazer Prime XP Temperature Ablation Catheter,Blazer Solid-Tip Ablation…
FDA device listing 1842603510 · Boston Scientific Corporation
Key facts
| Proprietary names | Blazer II XP Temperature Ablation Catheter,Blazer Prime XP Temperature Ablation Catheter,Blazer Solid-Tip Ablation Cather Cable, Sterile Cable,Cable, IntellaNav Ablation Catheter,Cable IntellaTip MiFi XP Sterile Cable,Electrophysiology Cable Non-Sterile Cable,INTELLAGEN Catheter Adapter Cable 0.3 Meter,INTELLAGEN ECG Connection Cable 3 Meter,INTELLAGEN Foot Pedal,INTELLAGEN Foot Pedal Extension… |
|---|---|
| Owner/operator | Boston Scientific Corporation |
| Owner/operator number | 9912058 |
| Premarket submissions | P020025 |
| Product codes | LPB, OAD |
| Device names | LPB - Cardiac Ablation Percutaneous Catheter, OAD - Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LPB, ORCA1.OAD |
| Review panels | Cardiovascular |
| Registered establishments | Boston Scientific Corporation, BOSTON SCIENTIFIC CORPORATION, Boston Scientific Limited |
| Establishment registrations | 2124215, 9681260, 1000121056, 3004859241, 3007695959, 3010705768 |
| FEI numbers | 2124215, 1000121056, 3002806565, 3004859241, 3007695959, 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