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 15, 2026, FDA's public records list Cardiovascular Imaging Systems, Inc. with 19 510(k) clearances. The most recent is a 510(k) clearance dated Jun 20, 1997: BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGI….
| Jun 20, 1997 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/K970049 · ITX | 510(k) clearances |
| Aug 1, 1994 | MICROVIEW II/MICRORAIL II CATHETERSK942231 · DQO | 510(k) clearances |
| Oct 15, 1993 | AUTOMATIC PULL BACK DEVICEK933517 · DQX | 510(k) clearances |
| Jul 21, 1993 | CVIS INSIGHT IMAGING GUIDE CATHETERK930232 · DQO | 510(k) clearances |
| Jun 29, 1993 | CVIS INSIGHT IMAGING CATHETERK924922 · DQO | 510(k) clearances |
| Jun 2, 1993 | CVIS LONGVIEWK930311 · DQO | 510(k) clearances |
| Jul 16, 1992 | CBIS CATHETER PULL-BACK DEVICEK921879 · DQO | 510(k) clearances |
| Jul 13, 1992 | CVIS INSIGHT III SYSTEMK921750 · ITX | 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
