Data / Medical devices / Costa Rica / Abbott Vascular
Abbott Vascular: FDA-registered device maker in El Coyol Alajuela, Costa Rica, 11 510(k) clearances
Abbott Vascular is registered with the FDA (registration 3009564766) in El Coyol Alajuela, Costa Rica. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009564766
- Address
- 52 Calle 3 B31 Coyol Free Zone, El Coyol Alajuela, Costa Rica, 20102
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 12, 2011
- Registered through
- 2026
- Brand names listed
- Armada 18 PTA Catheter, Armada 35 and 35LL Dilatation Catheters, Armada14 XT Dilatation Catheter, Mini Trek II OTW, Mini Trek II OTW (1.20 LTD IND, Mini Trek II OTW (1.50-20), Mini Trek OTW, Mini Trek OTW Dilatation Catheters and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transducer, Pressure, Catheter Tip | DXO | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| June 30, 2022 | K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 24, 2018 | K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 28, 2018 | K180558 | PressureWire X | DXO | Substantially Equivalent | St. Jude Medical (Now Part of Abbott Medical) | accessdata.fda.gov |
| July 6, 2015 | K151317 | Armada 18 PTA Catheter | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| January 30, 2013 | K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 15, 2012 | K121352 | ARMADA 14XXT PTA CATHETER | DQY | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 6, 2012 | K113464 | NC TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| October 3, 2011 | K111899 | ARMADA 35/35LL PTA CATHETER | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| February 11, 2011 | K110134 | NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| January 10, 2011 | K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| December 30, 2010 | K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Catheter, Percutaneous
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Wire, Guide, Catheter
- All makers of Transducer, Pressure, Catheter Tip
Updated June 30, 2022. 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.