Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiosolutions, 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) |
|---|---|---|---|---|---|
| K140015 | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER | Cardiosolutions, Inc. | 2014-02-05 | 34 | 0 |
| K131332 | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER | Cardiosolutions, Inc. | 2013-07-19 | 71 | 0 |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | 2011-07-14 | 560 | 0 |
| K094062 | PERCU-PRO GUIDEWIRE | Cardiosolutions, Inc. | 2010-09-27 | 270 | 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