Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Boston ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Cardiothoracic Systems with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 4, 2001: GUIDANT AXIUS CORONARY SHUNT.
| Apr 4, 2001 | GUIDANT AXIUS CORONARY SHUNTK010117 · DXC | 510(k) clearances |
| Jul 28, 1999 | VOYAGER QUAD CANNULAK983270 · DWF | 510(k) clearances |
| Jan 13, 1999 | HEART-LIFT BALLOON POSITIONERK982419 · MWS | 510(k) clearances |
| Nov 13, 1998 | BLOWER/MISTERK983135 · FQH | 510(k) clearances |
| Mar 17, 1998 | CTS MIDCAB STITCHERK963965 · GEI | 510(k) clearances |
| Oct 30, 1997 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNTK970638 · DXC | 510(k) clearances |
| Apr 3, 1997 | CTS MIDCAB CORONARY SHUNTK963503 · DXC | 510(k) clearances |
| Jan 16, 1997 | CTS MIDCAB/SVH BIPOLAR SCISSORSK963930 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
