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Abbott Vascular

US

Last updated September 17, 2026

Information

Country
US
Address
26531 YNEZ RD., Temecula, CA, 92591
Website
av.abbott.com
LinkedIn
—
Facebook
—
Phone
+1(800)227-9902
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2024168
DUNS Number
849716605

Catalogue (1935)

Page 38 of 39
DeviceModel / ReferenceRegistriesClassStatus
Tad™ 1012069-04
FDA UDI
Class IIActive
Xience Xpedition 1074275-23
FDA UDI
Class IIIActive
XIENCE Sierra™ 1550250-23
FDA UDI
Class IIIActive
Hi-Torque Intermediate 22317H-901
FDA UDI
Class IIUnknown
Xience Nano 1009544-12
FDA UDI
Class IIIUnknown
Xience Xpedition 1165325-08
FDA UDI
Class IIIActive
Xience Xpedition 1165250-15
FDA UDI
Class IIIUnknown
Copilot 1003331
FDA UDI
Class IIActive
Nc Trek Neo™ 1400300-06
FDA UDI
Class IIActive
Xience Alpine 1145250-15
FDA UDI
Class IIIActive
Xience Alpine 1145350-08
FDA UDI
Class IIIActive
Xience Xpedition 1074225-18
FDA UDI
Class IIIActive
XIENCE Sierra™ 1550400-18
FDA UDI
Class IIIActive
Xience Xpedition 1074325-28
FDA UDI
Class IIIActive
Xience Alpine 1145275-33
FDA UDI
Class IIIActive
XIENCE Sierra™ 1550300-08
FDA UDI
Class IIIActive
Xience Xpedition 1165250-23
FDA UDI
Class IIIUnknown
Xience Xpedition 1165325-23
FDA UDI
Class IIIActive
Cross-it 1003310H
FDA UDI
Class IIActive
Acculink™ 1011337-20
FDA UDI
Class IIIActive
JETi™ WV6203A
FDA UDI
Class IIActive
Chito-Seal K021062
FDA 510(k)
UActive
NC TREK NEO Coronary Dilatation Catheter K220634
FDA 510(k)
Class IIActive
Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires K191173
FDA 510(k)
Class IIActive
Perclose Vascular Suture Delivery Device K001703
FDA 510(k)
Class IIActive
Steerable Guide Catheter K112239
FDA 510(k)
Class IIActive
Fox Plus Pta Catheter K080925
FDA 510(k)
Class IIActive
Hi-Torque Versaturn Guide Wire K141782
FDA 510(k)
Class IIActive
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 K180040
FDA 510(k)
Class IIActive
Hi-Torque Command Guide Wire Family K122573
FDA 510(k)
Class IIActive
HI-TORQUE TurnTrac Guide Wire Family K173795
FDA 510(k)
Class IIActive
Foxcross Pta Catheter K081417
FDA 510(k)
Class IIActive
Fox Sv Pta Catheter K092286
FDA 510(k)
Class IIActive
Hi-Torque Balance K152709
FDA 510(k)
Class IIActive
Hi-Torque Progress Guide Wire Family K091825
FDA 510(k)
Class IIActive
Hi-Torque JET Guide Wire Family K142415
FDA 510(k)
Class IIActive
Modification To:xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Models 14819, 14820, 14821, 14822, 14822 K032929
FDA 510(k)
Class IIActive
Mini Trek Rx 1.20 Mm Coronary Dilatation Catheter, Mini Trek Otw 1.20 Mm Coronary Dilatation Catheter K110617
FDA 510(k)
Class IIActive
HI-TORQUE PROCEED Guide Wire Family K201834
FDA 510(k)
Class IIActive
Mini Trek Rx Coronary Dilatation Catheter (including 1.20 Mm Size), Mini Trek Otw Coronary Dilatation Catheter (includin K123279
FDA 510(k)
Class IIActive
Supercross Catheter K001856
FDA 510(k)
Class IIActive
Emboshield Nav6 Embolic Protection System K121015
FDA 510(k)
Class IIActive
RX ACCUNET Embolic Protection System K153086
FDA 510(k)
Class IIActive
Armada 35/35ll Pta Catheter K111899
FDA 510(k)
Class IIActive
Modification To Rx Herculink Elite Biliary Stent System K063481
FDA 510(k)
Class IIActive
Armada 14xxt Pta Catheter K121352
FDA 510(k)
Class IIActive
Starclose Introducer Set Model- 1002 K060902
FDA 510(k)
Class IIActive
Nc Trek Otw Coronary Dilatation Catheter K113464
FDA 510(k)
Class IIActive
Viatrac 14 Plus Peripheral Dilatation Catheter K221057
FDA 510(k)
Class IIActive
Wz Self-Expanding Stent Transhepatic Biliary System K031331
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

  • Abbott Vascular CLONMEL Tipperary · IE FEI 3005718570
  • Abbott Vascular El Coyol Alajuela · CR FEI 3009564766