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Volcano Corporation

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

Total Devices13
Categories5
Latest FDA decision2021-04-15
TypeNumberDevice NameCodeDateActions
510(k) K210235 Verrata PLUS Pressure Guide WireDQX2021-04-15 View
510(k) K203719 IntraSight MobileIYO2021-01-19 View
510(k) K202543 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-09-28 View
510(k) K192886 OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipDQX2020-03-26 View
510(k) K190626 SyncVision SystemOWB2019-04-12 View
510(k) K190078 IntraSightDSA2019-02-11 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 SystemIYO2018-04-11 View
510(k) K172455 CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation KitIYO2017-10-25 View
510(k) K172574 SyncVision SystemOWB2017-10-05 View
510(k) K170385 CORE M2 Vascular SystemIYO2017-04-06 View
510(k) K160583 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipOBJ2016-10-26 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-TipDQX2016-09-20 View
510(k) K161756 SyncVision SystemOWB2016-09-05 View
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