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Catheter Precision, Inc.

FDA Regulatory Profile

Catheter Precision, Inc. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 2, 2025 · VAI
Latest 510(k)
Sep 14, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 2, 2025Fort Mill, SCDevicesVoluntary Action Indicated (VAI)3010728615
Jul 24, 2019Fort Mill, SCDevicesNo Action Indicated (NAI)3010728615

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
K200313VIVOSep 14, 2020
K183195VIVOJun 14, 2019

FDA data resources