I have been the sole regulatory contributor for the Atherectomy and Thrombectomy U.S. regulatory 510(k) submissions, Investigational Device Exemption (IDE) and a key contributor for CE mark approvals. These submissions include pre-submission discussions as well as pre-clinical GLP, First-in-Human, and US clinical trials.

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US Regulatory Submissions

CE Mark

European Regulatory Submissions

  • CE mark for European Union (EU) commercialization for the Revolution Peripheral Atherectomy System & Guidewire