Low RiskFDA Device

Volcano Corp: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications

Agency Publication Date: June 29, 2022

Affected Products

Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 , ; UDI/DI: 00845225002329

Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797

All Lots containing IFU Part Number 300004856772/A Revision Date: 05/2021 ,; UDI/DI: 00845225002596

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90252

Status: Active

Manufacturer: Volcano Corp

Manufactured In: United States

Units Affected: 2 products (14.031 units; 7,520 units)

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Sources: FDA iRES · Raw API Response

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