# Abbott Vascular-Cardiac Therapies

- Location (FDA's records): Temecula, CA
- FDA decisions: 7 (2010–2012): 6 510(k) clearances and 1 original PMA approval
- Product codes: LOX (3), DQX (3), NIO (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 15 (1 its own)
- Recalls linked to its devices: 20 (20 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guidant Corp.: 3 (https://510kreport.com/company/guidant)
- Guidcorp: 1 (https://510kreport.com/company/guidcorp)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Abbott Vascular: 10 (https://510kreport.com/company/abbott-vascular)
- Natec Medical, Ltd.: 2 (https://510kreport.com/company/natec-medical)
- Meril Life Sciences Private Limited: 1 (https://510kreport.com/company/meril-life-sciences-private)
- Medinol, Ltd.: 1 (https://510kreport.com/company/medinol)

## Its most-cited devices
- K103101: HI-Torque Balance Middleweight Elite (2011), cited by 4
- K110134: NC Trek RX Coronary Dilatation Catheter (2011), cited by 3
- K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter (2010), cited by 2
- K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter (2011), cited by 2
- K101116: HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with (2010), cited by 2
- K112957: HI-Torque Powerturn (2011), cited by 2

## Recent decisions
- P110043: Omnilink Elite Peripheral Balloon-Expandable Stent System (Jul 31, 2012)
- K112957: HI-Torque Powerturn (Nov 8, 2011)
- K110134: NC Trek RX Coronary Dilatation Catheter (Feb 11, 2011)
- K103101: HI-Torque Balance Middleweight Elite (Feb 10, 2011)
- K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter (Jan 10, 2011)
- K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter (Dec 30, 2010)
- K101116: HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with (Jun 23, 2010)

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