Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Volcano Corporation

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories5
Latest Approval2021-04-15
TypeNumberDevice NameCodeDate
510(k) K210235 Verrata PLUS Pressure Guide Wire DQX 2021-04-15 View
510(k) K203719 IntraSight Mobile IYO 2021-01-19 View
510(k) K202543 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip DQX 2020-09-28 View
510(k) K192886 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip DQX 2020-03-26 View
510(k) K190626 SyncVision System OWB 2019-04-12 View
510(k) K190078 IntraSight DSA 2019-02-11 View
510(k) K173860 s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System IYO 2018-04-11 View
510(k) K172455 CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit IYO 2017-10-25 View
510(k) K172574 SyncVision System OWB 2017-10-05 View
510(k) K170385 CORE M2 Vascular System IYO 2017-04-06 View
510(k) K160583 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip OBJ 2016-10-26 View
510(k) K161887 Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip DQX 2016-09-20 View
510(k) K161756 SyncVision System OWB 2016-09-05 View
↑