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.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cryo Vascular Systems with 7 510(k) clearances. The most recent is a 510(k) clearance dated Aug 5, 2005: POLAR CATH PERIPHERAL DILATATION SYSTEM.
| Aug 5, 2005 | POLAR CATH PERIPHERAL DILATATION SYSTEMK051916 · LIT | 510(k) clearances |
| Nov 5, 2004 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK042230 · DQY | 510(k) clearances |
| Oct 12, 2004 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEMK042541 · DQY | 510(k) clearances |
| Feb 10, 2004 | POLARCATH PERIPHERAL DILATATION SYSTEMK033622 · DQY | 510(k) clearances |
| Aug 29, 2003 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEMK030742 · LIT | 510(k) clearances |
| Feb 19, 2003 | CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNITK023463 · DQY | 510(k) clearances |
| Sep 20, 2002 | CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATERK022061 · DQY | 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
