Vectracor, Inc.

FDA Regulatory Profile

Vectracor, Inc. has 0 FDA recalls, 5 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 24, 2017 · NAI
Latest 510(k)
Aug 28, 2018

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 24, 2017Maple Grove, MNDevicesNo Action Indicated (NAI)1000520092
Sep 27, 2017Totowa, NJDevicesVoluntary Action Indicated (VAI)3009443693
Jul 24, 2013Maple Grove, MNDevicesNo Action Indicated (NAI)1000520092
Nov 6, 2012Totowa, NJDevicesVoluntary Action Indicated (VAI)3009443693
Jun 30, 2011Maple Grove, MNDevicesNo Action Indicated (NAI)1000520092

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
K173952Universal SmartECGAug 28, 2018
K140852VECTRAPLEX CMSJan 30, 2015
K102378VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMINov 2, 2011