Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott (Formerly Thoratec Corporation) · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulat | Abbott (Formerly Thoratec Corporation) | 2022-12-08 | 150 | 1 |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arte | Abbott (Formerly Thoratec Corporation) | 2020-03-06 | 29 | 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