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FDA 510(k), K130391, EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
FDA 510(k), K130391, EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
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510(K) Number: K130391
Device Name: EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 02/15/2013
Decision Date: 07/10/2013
Regulation Medical Specialty: Cardiovascular
Device Name: EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 02/15/2013
Decision Date: 07/10/2013
Regulation Medical Specialty: Cardiovascular
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