Data / Medical devices / Costa Rica / Abbott Medical Costa Rica Ltda.
Abbott Medical Costa Rica Ltda.: FDA-registered device maker in El Coyol Alajuela, Costa Rica, 29 510(k) clearances and 4 PMA approvals
Abbott Medical Costa Rica Ltda. is registered with the FDA (registration 3008452825) in El Coyol Alajuela, Costa Rica. It lists 11 device types. The FDA files 29 510(k) clearances and 4 PMA approvals under its listings, the newest dated September 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008452825
- Address
- Edificio #44 Calle 0, Ave. 2 Zona Franca Coyol, El Coyol Alajuela, Costa Rica, 1897-4050
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 7, 2007
- Registered through
- 2027
- Brand names listed
- Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507, Advisor HD Grid Mapping Catheter, Sensor Enabled, Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519, Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532, Advisor HD Grid High Density Mapping Catheter, Sensor Enabled, D-AVHD-DF16, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, D-AVSE-D10-F15 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | 3 | Manufacturer | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | 3 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | 3 | Manufacturer | accessdata.fda.gov |
| Catheter, Ultrasound, Intravascular | OBJ | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | 3 | Manufacturer | accessdata.fda.gov |
| Reprocessed Intravascular Ultrasound Catheter | OWQ | 2 | Manufacturer | accessdata.fda.gov |
| Trocar | DRC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2026 | K261729 | EnSite X EP System | DQK | Substantially Equivalent | Abbott Medical | accessdata.fda.gov |
| September 25, 2025 | K252013 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 30, 2025 | K251234 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 20, 2025 | K251231 | ViewFlex X ICE Catheter, Sensor Enabled | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 13, 2024 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| August 9, 2024 | K242016 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 9, 2024 | K241372 | Advisor HD Grid X Mapping Catheter, Sensor Enabled | MTD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 13, 2024 | K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| August 10, 2023 | K231415 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 27, 2022 | K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 7, 2022 | K223077 | ViewFlex Xtra ICE Catheter | OBJ | Substantially Equivalent | Irvine Biomedical, A St. Jude Medical Company | accessdata.fda.gov |
| August 18, 2022 | K221213 | EnSite X EP System | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| November 11, 2021 | K213364 | EnSite X EP System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| October 22, 2021 | K212061 | EnSite X EP System | DQK | Substantially Equivalent | Abbott | accessdata.fda.gov |
| November 25, 2020 | K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 26, 2020 | K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 17, 2019 | K192037 | Advisor VL Circular Mapping Catheter, Sensor Enabled | DRF | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 23, 2018 | K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | MTD | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| December 13, 2016 | K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 13, 2016 | K160210 | EnSite Precision Cardiac Mapping System v2.0 | DQK | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 15, 2015 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 19, 2014 | K133853 | VIEWFLEX XTRA ICE CATHETER | OBJ | Substantially Equivalent | Irvine Biomedical, Inc., A St. Jude Medical Company | accessdata.fda.gov |
| May 10, 2011 | K110450 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 13, 2009 | K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 9, 2008 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 12, 2006 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 11, 1997 | K961924 | IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM | DRF | Substantially Equivalent | Irvine Biomedical, Inc. | accessdata.fda.gov |
| September 18, 1989 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | P250022 | Volt PFA System | QZI | 10 | October 15, 2026 | accessdata.fda.gov |
| May 18, 2023 | P220013 | TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C | OAE | 32 | September 22, 2026 | accessdata.fda.gov |
| October 24, 2014 | P130026 | TACTICATH QUARTZ SET | OAE | 99 | August 7, 2026 | accessdata.fda.gov |
| January 25, 2012 | P110016 | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | OAD | 91 | August 7, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- All makers of Introducer, Catheter
- All makers of Catheter, Intracardiac Mapping, High-Density Array
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.