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Abbott Vascular

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories9
Latest FDA decision2026-07-31
TypeNumberDevice NameCodeDateActions
PMA P110019 Coronary drug-eluting stentNIQ2026-07-31 View
PMA P040012 Stent, carotidNIM2025-10-22 View
PMA P110001 STENT, RENALNIN2025-10-22 View
PMA P020047 STENT, CORONARYMAF2023-06-14 View
510(k) K220634 NC TREK NEO Coronary Dilatation CatheterLOX2022-06-30 View
510(k) K221057 Viatrac 14 Plus Peripheral Dilatation CatheterLIT2022-05-05 View
510(k) K201834 HI-TORQUE PROCEED Guide Wire FamilyDQX2020-07-30 View
510(k) K200144 HI-TORQUE Steelcore Bare Guide WireDQX2020-04-08 View
510(k) K193126 HI-TORQUE InfilTrac Guide Wire FamilyDQX2019-12-11 View
510(k) K191173 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE2019-07-25 View
510(k) 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 CatheterLOX2018-08-24 View
510(k) K173795 HI-TORQUE TurnTrac Guide Wire FamilyDQX2018-01-12 View
510(k) K172394 Steerable Guide CatheterDRA2017-09-06 View
510(k) K172073 Hi-Torque Command 18 Guide WireDQX2017-08-25 View
510(k) K161985 Steerable Guide CatheterDRA2016-08-07 View

Related Clinical Trials

NCT00698607Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTingCOMPLETEDNCT05650411Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM)RECRUITING
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