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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Emerge Monorail PTCA Dilatation Catheter; Emerge Over-The-Wire PTCA Dilatation Catheter; Emerge Push Monorail PTCA Dilatation Catheter; Emerge Push Over-The-Wire PTCA 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: Boston Scientific Corp., Marina Bay Cust. Fulfillment Center
Registered Establishment Number: 1225687
Owner/Operator: Boston Scientific Corporation
Owner/Operator Number: 9912058
Establishment Operations: Manufacturer
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