510(k) Report

FDA applicant

Guidant Corp.

Santa Clara, CA89 decisions1997–200755 recalls

FDA records 89 decisions for Guidant Corp. (Santa Clara, CA) from 1997 to 2007: 86 510(k) clearances and 3 original PMA approvals. Most are in product codes DQX (Wire, Guide, Catheter) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 107 predicates, 47 of them its own earlier devices. 55 recalls are linked to its devices, 12 Class I.

FDA’s records also spell it “Guidant Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Guidant Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008: 22009: 42010: 12011: 22013: 12017: 42018: 22021: 5, 3 Class I2023: 12024: 3, 3 Class I2025: 5, 5 Class I2026 (partial year): 1, 1 Class I
2007high 5 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Guidant Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guidant Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQXWire, Guide, Catheter27decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts20decisions
  • DQYCatheter, Percutaneous14decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass4decisions
  • LITCatheter, Angioplasty, Peripheral, Transluminal4decisions
  • NTETemporary Carotid Catheter For Embolic Capture4decisions

Also: GCJ (3), DRB (3), GEI (2), MOU (1), DTD (1), NEY (1).

Whose devices does it build on?

Its devices cite 107 predicates; 47 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 157 times; 47 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991102Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 19997cite it
  • K990639Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic Coating.Guidant Corp. · 19997cite it
  • K042218Accunet Embolic Protection System, RX Accunet Embolic Protection SystemGuidant Corp. · 20047cite it
  • K013833HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating, #1009659,1009659J…Guidant Corp. · 20026cite it
  • K973494HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance Middleweight Guide…Guidant Corp. · 19976cite it
  • K041981Guidant Vasoview 6 Harvesting Cannula, Model VH-2000; Guidant Vasoview 6 Accessory Pack, Model VH-2004Guidant Corporation · 20046cite it

What has FDA decided for it lately?

  • P050046Acuity Steerable Lead SystemGuidant Corp. · 2007
  • K061865Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp. · 2006
  • K061453HI-Torque Whisper View Guide WireGuidant Corp. · 2006
  • K060449HI-Torque Advance and Advance Lite Guide WireGuidant Corporation · 2006
  • K053459Omnilink .035 Biliary Stent SystemGuidant Corporation · 2006
  • K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
  • K053019Acuity Steerable Stylet AccessoryGuidant Corporation · 2006
  • K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation · 2006

All 74 as Guidant Corp. →All 15 as Guidant Corporation →

What has been recalled?

55 recalls linked to its devices; the latest:

  • P030005Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…Mar 19, 2026Class I
  • P030005Model Number U225 VISIONIST CRT-P ELAug 20, 2025Class I
  • P030005Model Number U125, VALITUDE CRT-P ELAug 20, 2025Class I
  • P030005Model Number U226, VISIONIST CRT-P ELAug 20, 2025Class I
  • P030005Model Number U228, VISIONIST CRT-P EL MRIAug 20, 2025Class I
  • P030005Model Number U128, VALITUDE CRT-P EL MRIAug 20, 2025Class I

Other applicant names beginning “Guidant”

FDA records each applicant name separately; these may or may not be the same firm.

Guidant Corporation, Cardiac Surgery 8Guidant Cardiac and Vascular Surgery 7Guidant Endovascular Solutions, Inc. 1