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Volcano Atheromed, Inc.

FDA Regulatory Profile

Volcano Atheromed, Inc. has 0 FDA recalls, 2 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 8, 2016 · NAI
Latest 510(k)
Jun 14, 2021

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 8, 2016Menlo Park, CADevicesNo Action Indicated (NAI)3008847191
May 11, 2016Menlo Park, CADevicesNo Action Indicated (NAI)3008847191

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemJun 14, 2021
K193197QuickClear Mechanical Thrombectomy SystemApr 20, 2020
K182972Phoenix Atherectomy SystemDec 20, 2018
K181877Phoenix 2.4mm Atherectomy Plus SystemDec 17, 2018
K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm…Aug 24, 2017
K1511452.4mm X 127 cm Phoenix Atherectomy Deflecting SystemMay 26, 2015
K1433281.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix…Dec 19, 2014

FDA data resources