Abbott Vascular

FDA Device Registration & Listing · El Coyol Alajuela, CR · Registration 3009564766

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009564766
FEI Number
3009564766
Entity Name
Abbott Vascular
City/State/Country
El Coyol Alajuela, CR
Establishment Address
52 Calle 3, B31 Coyol Free Zone, El Coyol Alajuela 20102, CR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123279
PMA Number
N/A

All Registered Proprietary Names

Trek RX; Mini Trek RX (1.50-20 Global); Mini Trek RX (1.20 LTD IND); NC TREK OTW CORONARY DILATATION CATHETER Armada 35 and 35LL Dilatation Catheters PressureWire X NC TREK RX CORONARY DILATATION CATHETER Trek RX Trek OTW Mini Trek II OTW (1.20 LTD IND Mini Trek OTW Dilatation Catheters Mini Trek RX Mini Trek II OTW (1.50-20) Armada14 XT Dilatation Catheter NC TREK NEO NC TREK RX Coronary Dilatation Catheter Mini Trek OTW Mini Trek RX Mini Trek II OTW

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2019-12-06
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-04-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-10-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-10-17
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2018-06-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-06-28
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency Cardiovascular Class 2 870.2910 2018-06-28
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2018-06-22
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2011-01-12
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-08-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-08-16
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2022-07-07
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2011-01-12
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2018-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

Keith Krohn Business: Abbott Vascular Email: keith.krohn@abbott.com Phone: (951) 9143324

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009564766. Last updated year: 2026. Please use registration number 3009564766 when referencing this establishment in official correspondence.
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