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FDA 510(k), K160173, Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
FDA 510(k), K160173, Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
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510(K) Number: K160173
Device Name: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Manufacturer: Boston Scientific Corporation
Device Classification Name: echocardiograph
Regulation Number: 870.2330
Classification Product Code: DXK
Date Received: 01/27/2016
Decision Date: 02/26/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Manufacturer: Boston Scientific Corporation
Device Classification Name: echocardiograph
Regulation Number: 870.2330
Classification Product Code: DXK
Date Received: 01/27/2016
Decision Date: 02/26/2016
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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