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

Guidant Cardiac and Vascular Surgery · Predicate Candidate Screening

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

90 daysmedian FDA review time
402 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K003889ANCURE SHEATH MODEL # 40315, 40320, 40325Guidant Cardiac and Vascular Surgery2002-01-244020
K001694GUIDANT RETRIEVER DEVICEGuidant Cardiac and Vascular Surgery2001-05-153470
K003495ANCURE LLIAC BALLOON CATHETERGuidant Cardiac and Vascular Surgery2001-02-07860
K002676ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCERGuidant Cardiac and Vascular Surgery2000-10-30630
K970470EVT EXPANDABLE SHEATHGuidant Cardiac and Vascular Surgery1997-07-311740
K970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERGuidant Cardiac and Vascular Surgery1997-05-08900
K970608EVT MARKER BOARDGuidant Cardiac and Vascular Surgery1997-04-21620

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