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FDA 510(k)

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

K-Number: K191175 · 2019-06-27

ApplicantAcist Medical Systems, Inc.
Decision Date2019-06-27
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-06-27 under approval number K191175. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is a medical device that received FDA 510(k) clearance on 2019-06-27. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K191175.

When was ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System approved by the FDA?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System received FDA 510(k) clearance on 2019-06-27, under approval number K191175.

What company makes ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is manufactured by Acist Medical Systems, Inc..

What is the FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

The FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is OBJ.

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Other Devices by Acist Medical Systems, Inc.

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Related Devices (Code: OBJ)

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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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