FDA device listing
PulseSelect™ Pulsed Field Ablation (PFA),Sphere 360
FDA device listing 1824756627 · Medtronic, Inc.
Key facts
| Proprietary names | PulseSelect™ Pulsed Field Ablation (PFA),Sphere 360 |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Product codes | QZI |
| Device names | QZI - Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.QZI |
| Review panels | Cardiovascular |
| Registered establishments | Medtronic CryoCath LP, MEDTRONIC, INC., MEDTRONIC IRELAND |
| Establishment registrations | 2182208, 9612164, 3002648230 |
| FEI numbers | 2182208, 3002648230, 3002806434 |
| Establishment operations | Manufacturer, Specification Developer |
| 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