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FDA 510(k)

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

K-Number: K181042 · 2018-05-17

ApplicantBoston Scientific Corporation
Decision Date2018-05-17
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2018-05-17 under approval number K181042. 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 – PI 9 MHz Peripheral Imaging Catheter?

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is a medical device that received FDA 510(k) clearance on 2018-05-17. It is manufactured by Boston Scientific Corporation. The 510(k) number is K181042.

When was Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter approved by the FDA?

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter received FDA 510(k) clearance on 2018-05-17, under approval number K181042.

What company makes Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter?

Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter?

The FDA product code for Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter is DXK.

Related Clinical Trials

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Related Devices (Code: DXK)

K160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific Corporation

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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