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FDA 510(k)

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

K-Number: K193183 · 2020-03-20

ApplicantAcist Medical Systems, Inc.
Decision Date2020-03-20
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-03-20 under approval number K193183. 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 HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2020-03-20. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K193183.

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

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter received FDA 510(k) clearance on 2020-03-20, under approval number K193183.

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

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

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

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

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Other Devices by Acist Medical Systems, Inc.

K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System 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

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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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