Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Datascope Corp., Cardiac Assist Division · 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) |
|---|---|---|---|---|---|
| K122405 | AIR-BAND RADIAL COMPRESSION DEVICE | Datascope Corp., Cardiac Assist Division | 2012-11-09 | 94 | 0 |
| K122628 | SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHET | Datascope Corp., Cardiac Assist Division | 2012-09-06 | 9 | 2 |
| K120868 | MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCES | Datascope Corp., Cardiac Assist Division | 2012-04-20 | 29 | 6 |
| K091449 | DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCE | Datascope Corp., Cardiac Assist Division | 2009-06-18 | 31 | 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