Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Cardiothoracic Systems, Inc. — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

212 daysmedian FDA review time
531 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K010117GUIDANT AXIUS CORONARY SHUNTCardiothoracic Systems, Inc.2001-04-04780
K983270VOYAGER QUAD CANNULACardiothoracic Systems, Inc.1999-07-283140
K982419HEART-LIFT BALLOON POSITIONERCardiothoracic Systems, Inc.1999-01-131840
K983135BLOWER/MISTERCardiothoracic Systems, Inc.1998-11-13660
K963965CTS MIDCAB STITCHERCardiothoracic Systems, Inc.1998-03-175310
K970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNTCardiothoracic Systems, Inc.1997-10-302520
K963503CTS MIDCAB CORONARY SHUNTCardiothoracic Systems, Inc.1997-04-032120
K963930CTS MIDCAB/SVH BIPOLAR SCISSORSCardiothoracic Systems, Inc.1997-01-161070

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