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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Abbott Vascular-Vascular Solutions — Predicate Candidate Screening

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

101 daysmedian FDA review time
328 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090665EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODELAbbott Vascular-Vascular Solutions2009-05-22700
K090509FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342Abbott Vascular-Vascular Solutions2009-03-20220
K081523EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEMAbbott Vascular-Vascular Solutions2008-09-111010
K072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEMAbbott Vascular-Vascular Solutions2008-08-183280
K080264MODIFICATION TO: FOX PLUS PTA CATHETERAbbott Vascular-Vascular Solutions2008-03-26540
K072798VIATRAC 14 PLUS PERIPHERAL DILATION CATHETERAbbott Vascular-Vascular Solutions2008-01-311221

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