FDA device listing
Advisor™ HD Grid Sensor Enabled™, High Density Mapping Catheter,Advisor™ HD Grid X, Sensor Enabled™, High Density…
FDA device listing 1219462594 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Advisor™ HD Grid Sensor Enabled™, High Density Mapping Catheter,Advisor™ HD Grid X, Sensor Enabled™, High Density Mapping Catheter,Agilis™ NxT, Steerable Introducer,Agilis™ NxT Steerable Introducer Dual Reach™, Steerable Introducer,ViewFlex™ Eco, Reprocessed ICE Catheter,ViewFlex™ Xtra, ICE Catheter |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K251211 |
| Product codes | DYB, MTD, OBJ, OWQ |
| Device names | DYB - Introducer, Catheter, MTD - Catheter, Intracardiac Mapping, High-Density Array, OBJ - Catheter, Ultrasound, Intravascular, OWQ - Reprocessed Intravascular Ultrasound Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1200, 870.1220, 870.1340 |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical Costa Rica Ltda., Abbott Medical Mexico, S. de R.L. de C.V., IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2030404, 2182269, 3005334138, 3008452825, 3012179728, 3038966633 |
| FEI numbers | 2182269, 1000519796, 3005334138, 3008452825, 3012179728, 3038966633 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Reprocessor of Single Use Devices |
| 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