FDA applicant

Guidant Cardiac and Vascular Surgery

Menlo Park, CA7 decisions1997–20020 recalls

FDA records 7 decisions for Guidant Cardiac and Vascular Surgery (Menlo Park, CA) from 1997 to 2002: 7 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Cardiac and Vascular Surgery’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guidant Cardiac and Vascular Surgery since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Guidant Cardiac and Vascular Surgery’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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Other applicant names beginning “Guidant”

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

Guidant Corp. 89 Guidant Corporation, Cardiac Surgery 8 Guidant Endovascular Solutions, Inc. 1

Guidant Cardiac and Vascular Surgery

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Guidant”