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

Abbott Vascular-Cardiac Therapies · Predicate Candidate Screening

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

77 daysmedian FDA review time
113 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112957HI-TORQUE POWERTURNAbbott Vascular-Cardiac Therapies2011-11-08350
K110134NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies2011-02-112417
K103101HI-TORQUE BALANCE MIDDLEWEIGHT ELITEAbbott Vascular-Cardiac Therapies2011-02-101130
K103110MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETEAbbott Vascular-Cardiac Therapies2011-01-10940
K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONAbbott Vascular-Cardiac Therapies2010-12-307720
K101116HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHAbbott Vascular-Cardiac Therapies2010-06-23630

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