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 CardiacAssist with 21 510(k) clearances. The most recent is a 510(k) clearance dated Jan 19, 2024: LifeSPARC System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 19, 2024 | LifeSPARC SystemK233736 · QNR | 510(k) clearances |
| Oct 6, 2023 | ProtekDuo Veno-Venous Cannula SetsK232480 · PZS | 510(k) clearances |
| Aug 3, 2023 | LifeSPARC SystemK232132 · KFM | 510(k) clearances |
| Nov 15, 2022 | LifeSPARC SystemK211830 · QNR | 510(k) clearances |
| Mar 26, 2021 | TandemHeart Pump and Escort ControllerK202751 · QNR | 510(k) clearances |
| Jul 9, 2019 | LifeSPARC Pump, LifeSPARC ControllerK183623 · KFM | 510(k) clearances |
| May 25, 2018 | ProtekDuo Mini Veno-Venous Cannula SetK181150 · DWF | 510(k) clearances |
| Jan 6, 2017 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetK162181 · DRE | 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
