Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integrated Vascular Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K031583 | MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 | Integrated Vascular Systems, Inc. | 2003-06-16 | 26 | 0 |
| K030723 | IVS INTRODUCER SET, MODEL 1003 | Integrated Vascular Systems, Inc. | 2003-04-03 | 27 | 0 |
| K020879 | IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS | Integrated Vascular Systems, Inc. | 2002-09-25 | 191 | 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