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Concentric Medical Inc

8 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardio recall (Z-0116-2016)Concentric Medical Inc2015-10-09
Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Cathe recall (Z-0525-2015)Concentric Medical Inc2014-12-12
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retri recall (Z-0528-2015)Concentric Medical Inc2014-12-08
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombu recall (Z-2598-2014)Concentric Medical Inc2014-09-08
FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. Fl recall (Z-0655-2013)Concentric Medical Inc2013-01-08
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 9007 recall (Z-0899-2011)Concentric Medical Inc2011-01-12
Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035 recall (Z-0085-04)Concentric Medical Inc2004-07-20
Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037 recall (Z-0086-04)Concentric Medical Inc2004-07-20

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Every clearance here is in the API, with alerts when new ones post.