FDA device listing
ENSITE-AAF-01 EnSite™ X Amplifier Air Filter,ENSITE-ACBL-160-01 EnSite™ X EP System Connect Cable,ENSITE-ACBL-60-01…
FDA device listing 1897877020 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ENSITE-AAF-01 EnSite™ X Amplifier Air Filter,ENSITE-ACBL-160-01 EnSite™ X EP System Connect Cable,ENSITE-ACBL-60-01 EnSite™ X EP System Connect Cable,ENSITE-AM-2.0 EnSite™ X EP System Advanced Mapping Software License,ENSITE-AMD-01 EnSite™ X EP System, AutoMark Distance, Software License,ENSITE-AMP-01 EnSite™ X EP System Amplifier,ENSITE-AMP-02 EnSite™ X EP System Amplifier,ENSITE-AMPCART1-01… |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K231415 |
| Product codes | DQK |
| Device names | DQK - Computer, Diagnostic, Programmable |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1425 |
| Review panels | Cardiovascular |
| Registered establishments | Abbott Medical Costa Rica Ltda., IRVINE BIOMEDICAL. INC., St. Jude Medical, St. Jude Medical, Atrial Fibrillation Division, Inc., St. Jude Medical, Cardiology Division, Inc. |
| Establishment registrations | 2030404, 2184149, 3005334138, 3008452825, 3012179728 |
| FEI numbers | 1000139754, 1000519796, 3005334138, 3008452825, 3012179728 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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