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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: NC TREK RX Coronary Dilatation Catheter; Voyager NC Dilatation Catheter
Classification Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Product Code: LOX
Device Class: 2
Regulation Number: 870.5100
Medical Specialty: Cardiovascular
Registered Establishment Name: Abbott Vascular Costa Rica
Registered Establishment Number: 3009564766
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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