FDA device listing
Electrophysiology Cable,Electrophysiology Extension Cable,EnSite X EP System, Catheter Connector Cable…
FDA device listing 1244226634 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Electrophysiology Cable,Electrophysiology Extension Cable,EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL,EnSite™ X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL,EnSite™ X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL,EnSite™ X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL,EnSite™ X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL,EnSite™ X EP System Catheter… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | IKD |
| Device names | IKD - Cable, Electrode |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.1175 |
| Review panels | Physical Medicine |
| Registered establishments | IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2030404, 2182269, 2184149, 3005334138, 3012179728 |
| FEI numbers | 2182269, 1000139754, 1000519796, 3005334138, 3012179728 |
| Establishment operations | Complaint File Establishment, 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