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 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CardioSolutions with 5 510(k) clearances. The most recent is a 510(k) clearance dated Feb 5, 2014: CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER.
| Date | Record | Source |
|---|---|---|
| Feb 5, 2014 | CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCERK140015 · DYB | 510(k) clearances |
| Jul 19, 2013 | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCERK131332 · DYB | 510(k) clearances |
| Apr 24, 2012 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CMK120086 · DRA | 510(k) clearances |
| Jul 14, 2011 | PERCUPRO MESSENGER BALLOON CATHETERK094048 · DYG | 510(k) clearances |
| Sep 27, 2010 | PERCU-PRO GUIDEWIREK094062 · DQX | 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
