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FDA 510(k)

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

K-Number: K173063 · 2017-10-23

ApplicantAcist Medical Systems, Inc.
Decision Date2017-10-23
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 2017-10-23 under approval number K173063. 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 2017-10-23. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K173063.

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 2017-10-23, under approval number K173063.

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.

K172216ACIST RXi Mini System K171646ACISTCVi® Contrast Delivery System K190473ACIST RXi System and Navvus II Catheter K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

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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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