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FDA 510(k), K123837, PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
FDA 510(k), K123837, PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
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510(K) Number: K123837
Device Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Manufacturer: BIOSENSE WEBSTER, INC.
Device Classification Name: catheter, intracardiac mapping, high-density array
Regulation Number: 870.1220
Classification Product Code: MTD
Date Received: 12/13/2012
Decision Date: 03/05/2013
Regulation Medical Specialty: Cardiovascular
Device Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
Manufacturer: BIOSENSE WEBSTER, INC.
Device Classification Name: catheter, intracardiac mapping, high-density array
Regulation Number: 870.1220
Classification Product Code: MTD
Date Received: 12/13/2012
Decision Date: 03/05/2013
Regulation Medical Specialty: Cardiovascular
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