Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sequent Medical, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017-02-18 | 157 | 0 |
| K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015-08-28 | 148 | 0 |
| K132652 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | Sequent Medical, Inc. | 2013-12-20 | 116 | 1 |
| K123477 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | Sequent Medical, Inc. | 2013-03-19 | 126 | 0 |
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