Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list InterValve with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Dec 18, 2015: V8 Balloon Aortic Valvuloplasty Catheter.
| Date | Record | Source |
|---|---|---|
| Dec 18, 2015 | V8 Balloon Aortic Valvuloplasty CatheterK152150 · OZT | 510(k) clearances |
| Apr 3, 2015 | V8 Transluminal BAV CatheterK150343 · OZT | 510(k) clearances |
| Mar 14, 2014 | InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedurClass II · Leak issues were discovered through accelerated age testing. | Device recalls |
| Feb 11, 2014 | V8 TRANSLUMINAL BAV CATHETERK133607 · OZT | 510(k) clearances |
| Nov 22, 2013 | V8 TRANSLUMINAL BAV CATHETERK132728 · OZT | 510(k) clearances |
| Jan 31, 2013 | V8 TRANSLUMINAL BAV CATHETERK123111 · OZT | 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
