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FDA 510(k)

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System

K-Number: K203004 · 2020-12-17

ApplicantAcist Medical Systems, Inc.
Decision Date2020-12-17
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-12-17 under approval number K203004. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-17. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K203004.

When was ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System approved by the FDA?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System received FDA 510(k) clearance on 2020-12-17, under approval number K203004.

What company makes ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is manufactured by Acist Medical Systems, Inc..

What is the FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

The FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is DXT.

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Other Devices by Acist Medical Systems, Inc.

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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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