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FDA 510(k)

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

K-Number: K160173 · 2016-02-26

ApplicantBoston Scientific Corporation
Decision Date2016-02-26
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-02-26 under approval number K160173. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)?

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) is a medical device that received FDA 510(k) clearance on 2016-02-26. It is manufactured by Boston Scientific Corporation. The 510(k) number is K160173.

When was Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) approved by the FDA?

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) received FDA 510(k) clearance on 2016-02-26, under approval number K160173.

What company makes Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)?

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) is manufactured by Boston Scientific Corporation.

What is the FDA product code for Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)?

The FDA product code for Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) is DXK.

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Related Devices (Code: DXK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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