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Concentric Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
46
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0116-2016Class IIDistal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: August 19, 2015
Z-2598-2014Class IIMerci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in paJune 25, 2014
Z-0528-2015Class IITrevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is November 13, 2013
Z-0525-2015Class IIDistal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter isSeptember 26, 2013
Z-0655-2013Class IIFlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGateDecember 20, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)February 15, 2018
DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm,September 2, 2016
K1537298F FlowGate2 Balloon Guide CatheterJanuary 27, 2016
K150616Trevo XP ProVue Retriever (4x30mm)June 12, 2015
K143077Trevo XP ProVue Retriever (6X25mm)April 6, 2015
K133177MODIFIED HD GUIDE CATHETERFebruary 25, 2014
K133464MODIFIED TREVO PROVUE RETRIEVERJanuary 17, 2014
K132641MODIFIED TREVO PROVUE RETRIEVERJanuary 13, 2014
K131437MODIFIED CONCENTRIC MICROCATHETEROctober 11, 2013
K131492MODIFIED FLOWGATE BALLOON GUIDE CATHETEROctober 3, 2013
K122581MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254November 21, 2012
K122478MODIFIED TREVO RETRIEVEROctober 31, 2012
K120961TREVO RETRIEVERAugust 3, 2012
K112404CONCENTRIC BALLOON GUIDE CATHETERMarch 15, 2012
K113260MODIFIED CONCENTIRC MICROCATHETERMarch 9, 2012
K111619MODIFIED CONCENTRIC MICROCATHETERJuly 6, 2011
K110483MODIFIED HD GUIDE CATHETERApril 4, 2011
K093610MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153February 17, 2011
K102657CONCENTRIC BALLOON GUIDE CATHETERNovember 17, 2010
K092298MODIFICATION TO MODIFIED HD GUIDE CATHETERNovember 5, 2009