Concentric Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
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