# Guidant Corp.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 89 (1997–2007): 86 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Guidant Corp. (74); Guidant Corporation (15)
- Product codes: DQX (27), FGE (20), DQY (14), DTL (4), LIT (4), NTE (4), GCJ (3), DRB (3), GEI (2), MOU (1), DTD (1), NEY (1)
- Predicates its devices cite: 107 (47 its own); citations of its devices by later devices: 157 (47 its own)
- Recalls linked to its devices: 55 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Advanced Cardiovascular Systems, Inc.: 18 (https://510kreport.com/company/advanced-cardiovascular-systems)
- Origin Medsystems, Inc.: 6 (https://510kreport.com/company/origin-medsystems)
- Cordis Corp.: 6 (https://510kreport.com/company/cordis)
- Cardiac Pacemakers, Inc.: 5 (https://510kreport.com/company/cardiac-pacemakers)
- Guidant Corporation, Cardiac Surgery: 3 (https://510kreport.com/company/guidant-cardiac-surgery)
- Johnson & Johnson Interventional Systems: 3 (https://510kreport.com/company/johnson-johnson-interventional-systems)
- Peripheral Systems Group: 2 (https://510kreport.com/company/peripheral-systems-group)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)

## Firms that cite its devices most
- Abbott Vascular: 16 (https://510kreport.com/company/abbott-vascular)
- Asahi Intecc Co., Ltd.: 11 (https://510kreport.com/company/asahi-intecc)
- Boston Scientific Corp: 6 (https://510kreport.com/company/boston-scientific)
- Maquet Cardiovascular, LLC: 6 (https://510kreport.com/company/maquet-cardiovascular)
- St Jude Medical: 5 (https://510kreport.com/company/st-jude-medical)
- Jomed, Inc.: 5 (https://510kreport.com/company/jomed)
- Boston Scientific Scimed, Inc.: 4 (https://510kreport.com/company/boston-scientific-scimed)
- Biotronik, Inc.: 3 (https://510kreport.com/company/biotronik)

## Its most-cited devices
- K991102: Copilot Bleedback Control Valve, Model 1003331 (1999), cited by 7
- K990639: Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating. (1999), cited by 7
- K042218: Accunet Embolic Protection System, RX Accunet Embolic Protection System (2004), cited by 7
- K013833: HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J, 1009660, 10096 (2002), cited by 6
- K973494: HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide Wire with Hydg (1997), cited by 6
- K041981: Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004 (2004), cited by 6

## Recent decisions
- P050046: Acuity Steerable Lead System (Apr 13, 2007)
- K061865: Flex 10 Mis Ablation Probe, Model FLX10MI-05 (Jul 27, 2006)
- K061453: HI-Torque Whisper View Guide Wire (Jun 22, 2006)
- K060449: HI-Torque Advance and Advance Lite Guide Wire (May 30, 2006)
- K053459: Omnilink .035 Biliary Stent System (Apr 12, 2006)
- K053454: RX Herculink Elite Biliary Stent System (Mar 6, 2006)
- K053019: Acuity Steerable Stylet Accessory (Mar 3, 2006)
- K052965: Easytrak 2 Stylet, Models 4826, 4829, 4832. (Feb 13, 2006)

Source page: https://510kreport.com/company/guidant