5 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
FDA Enforcement
Class II
·Ongoing·Volcano Corp·August 6, 2025
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Enforcement
Class III
·Ongoing·Volcano Corp·July 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Enforcement
Class III
·Ongoing·Volcano Corp·July 6, 2022
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Enforcement
Class III
·Ongoing·Volcano Corp·April 20, 2022
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
FDA Enforcement
Class III
·Ongoing·Volcano Corp·April 20, 2022