FDA 510(k) K103110, Mini Trek and Trek RX/OTW Coronary Dilatation Catheters, by Abbott Vascular-Cardiac Therapies
FDA 510(k) K103110, Mini Trek and Trek RX/OTW Coronary Dilatation Catheters, by Abbott Vascular-Cardiac Therapies
Device Name: MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
Manufacturer: Abbott Vascular-Cardiac Therapies
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 10/08/2010
Decision Date: 01/10/2011
Regulation Medical Specialty: Cardiovascular
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