Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vascon, LLC — 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) |
|---|---|---|---|---|---|
| K053310 | VASCON ROAMER MICROCATHETER | Vascon, LLC | 2008-07-03 | 948 | 0 |
| K052004 | VASCON NEUROPATH GUIDING CATHETER | Vascon, LLC | 2006-01-19 | 178 | 24 |
| K043387 | VASCON POLARIS GUIDING CATHETER | Vascon, LLC | 2005-02-16 | 69 | 0 |
| K033633 | VASCON POLARIS GUIDING CATHETER | Vascon, LLC | 2004-02-18 | 91 | 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