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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AngioJet Drive Unit; AngioJet Pump Set; AngioJet Rheolytic Thrombectomy; AngioJet SpiroflexThrombectomy Cath; AngioJet Ultra Console; AngioJet XMI ThrombectomyCatheter; AngioJet XMI-RX+ Catheter; AngioJetSpiroflexVGThrombectomyCath; AngioJetUltra SpiroflexThrombectomy
Classification Name: CATHETER, CORONARY, ATHERECTOMY
Product Code: MCX
Device Class: 3
Registered Establishment Name: Bayer Medical Care Inc.
Registered Establishment Number: 2183460
Owner/Operator: Bayer Medical Care Inc.
Owner/Operator Number: 2520313
Establishment Operations: Manufacturer
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