FDA device listing
Barrx 60 RFA Focal Catheter,HALO60 Ablation Catheter
FDA device listing 1894490911 · Medtronic, Inc.
Key facts
| Proprietary names | Barrx 60 RFA Focal Catheter,HALO60 Ablation Catheter |
|---|---|
| Owner/operator | Medtronic, Inc. |
| Owner/operator number | 2112641 |
| Premarket submissions | K112454 |
| Product codes | GEI, KNS |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories, KNS - Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.4300, 878.4400 |
| Review panels | Gastroenterology & Urology, General & Plastic Surgery |
| Registered establishments | Medtronic Engineering and Innovation Center (MEIC) |
| Establishment registrations | 3018094310 |
| FEI numbers | 3018094310 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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