# Abbott Vascular

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 64 (1986–2022): 50 510(k) clearances and 14 original PMA approvals
- Names in FDA's records: Abbott Vascular (35); Abbott Vascular, Inc. (29)
- Product codes: DQX (19), LOX (8), LIT (7), NTE (4), MAF (3), FGE (3), DRA (3), DQY (3), NIQ (2), NIM (2), GAW (2), PNY (1)
- 510(k) review time since 2016: median 29 days, against 114 for FDA's reviews in the same codes and years (8 of 9 faster)
- Predicates its devices cite: 86 (27 its own); citations of its devices by later devices: 48 (27 its own)
- Recalls linked to its devices: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guidant Corp.: 16 (https://510kreport.com/company/guidant)
- Abbott Vascular-Cardiac Therapies: 10 (https://510kreport.com/company/abbott-vascular-cardiac-therapies)
- Abbott Vascular-Vascular Solutions: 8 (https://510kreport.com/company/abbott-vascular-vascular-solutions)
- Evalve, Inc.: 8 (https://510kreport.com/company/evalve)
- Invatec Innovative Technologies, S.R.L.: 3 (https://510kreport.com/company/invatec-innovative-technologies)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Guidcorp: 2 (https://510kreport.com/company/guidcorp)
- Ev3, Inc.: 1 (https://510kreport.com/company/ev3)

## Firms that cite its devices most
- Heraeus Medical Components, LLC: 2 (https://510kreport.com/company/heraeus-medical-components)
- Abbott Medical: 2 (https://510kreport.com/company/abbott-medical)
- Lydus Medical, Ltd.: 1 (https://510kreport.com/company/lydus-medical)
- Coreleader Biotech Co., Ltd.: 1 (https://510kreport.com/company/coreleader-biotech)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Contego Medical, Inc.: 1 (https://510kreport.com/company/contego-medical)
- Scion Cardio-Vascular, Inc.: 1 (https://510kreport.com/company/scion-cardio-vascular)
- Orbusneich Medical Trading, Inc.: 1 (https://510kreport.com/company/orbusneich-medical-trading)

## Its most-cited devices
- K072460: HI-Torque Balance Middleweight Universal II Guide Wire (2008), cited by 5
- K021062: Chito-Seal (2002), cited by 5
- K122573: HI-Torque Command Guide Wire Family (2012), cited by 5
- K102705: Armada 14 Pta Catheter (2010), cited by 4
- K091825: HI-Torque Progress Guide Wire Family (2009), cited by 3
- K110617: Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary Dilatation Catheter (2011), cited by 2

## Recent decisions
- K220634: NC TREK NEO Coronary Dilatation Catheter (Jun 30, 2022)
- K221057: Viatrac 14 Plus Peripheral Dilatation Catheter (May 5, 2022)
- K201834: HI-TORQUE PROCEED Guide Wire Family (Jul 30, 2020)
- K200144: HI-TORQUE Steelcore Bare Guide Wire (Apr 8, 2020)
- K193126: HI-TORQUE InfilTrac Guide Wire Family (Dec 11, 2019)
- K191173: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (Jul 25, 2019)
- 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 (Aug 24, 2018)
- K173795: HI-TORQUE TurnTrac Guide Wire Family (Jan 12, 2018)

Source page: https://510kreport.com/company/abbott-vascular