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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Guidant Corporation, Cardiac Surgery · Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

66 daysmedian FDA review time
115 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080169HEARTSTRING III PROXIMAL SEAL SYSTEMGuidant Corporation, Cardiac Surgery2008-02-08150
K041340GUIDANT MICROWAVE ABLATION SYSTEMGuidant Corporation, Cardiac Surgery2004-07-28690
K023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDGuidant Corporation, Cardiac Surgery2003-02-201150
K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEMGuidant Corporation, Cardiac Surgery2003-02-14660
K023629ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TGuidant Corporation, Cardiac Surgery2002-11-12150
K022718VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-Guidant Corporation, Cardiac Surgery2002-08-28130
K020701SYNCRUS INTERNAL CARDIOVERSION SYSTEMGuidant Corporation, Cardiac Surgery2002-05-24810
K020143VASOVIEW 5 HARVESTING CANNULAGuidant Corporation, Cardiac Surgery2002-02-20351

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda