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FDA 510(k), K120425, PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
FDA 510(k), K120425, PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
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510(K) Number: K120425
Device Name: PENTARAY NAV 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: 02/13/2012
Decision Date: 05/24/2012
Regulation Medical Specialty: Cardiovascular
Device Name: PENTARAY NAV 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: 02/13/2012
Decision Date: 05/24/2012
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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