Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific - Precision Vascular — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE | Boston Scientific - Precision Vascular | 2006-03-13 | 110 | 13 |
| K050964 | PV 1900 SYNCHRO 0.016 GUIDEWIRE | Boston Scientific - Precision Vascular | 2005-06-13 | 56 | 6 |
| K050630 | PIVOT STEERABLE MICROCATHETER | Boston Scientific - Precision Vascular | 2005-03-22 | 11 | 1 |
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