Atlas FDA

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

Boston Scientific/Medi-Tech — Predicate Candidate Screening

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

29 daysmedian FDA review time
100 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023870FLEXIMA BILIARY CATHETERBoston Scientific/Medi-Tech2002-12-20302
K020012MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETERBoston Scientific/Medi-Tech2002-01-29261
K012948MODIFICATION TO VAXCEL DIALYSIS CATHETERBoston Scientific/Medi-Tech2001-10-03290
K012952HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH Boston Scientific/Medi-Tech2001-10-02281
K011664IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific/Medi-Tech2001-09-071002

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