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FDA 510(k)

ACIST RXi System and Navvus II Catheter

K-Number: K190473 · 2019-09-13

ApplicantAcist Medical Systems, Inc.
Decision Date2019-09-13
Product CodeOBI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST RXi System and Navvus II Catheter is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K190473. The device is classified under product code OBI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIST RXi System and Navvus II Catheter?

ACIST RXi System and Navvus II Catheter is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K190473.

When was ACIST RXi System and Navvus II Catheter approved by the FDA?

ACIST RXi System and Navvus II Catheter received FDA 510(k) clearance on 2019-09-13, under approval number K190473.

What company makes ACIST RXi System and Navvus II Catheter?

ACIST RXi System and Navvus II Catheter is manufactured by Acist Medical Systems, Inc..

What is the FDA product code for ACIST RXi System and Navvus II Catheter?

The FDA product code for ACIST RXi System and Navvus II Catheter is OBI.

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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 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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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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