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FDA 510(k)

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

K-Number: K233904 · 2024-07-17

ApplicantAcist Medical Systems, Inc.
Decision Date2024-07-17
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is a medical device manufactured by Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-07-17 under approval number K233904. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is a medical device that received FDA 510(k) clearance on 2024-07-17. It is manufactured by Acist Medical Systems, Inc.. The 510(k) number is K233904.

When was ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ approved by the FDA?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ received FDA 510(k) clearance on 2024-07-17, under approval number K233904.

What company makes ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is manufactured by Acist Medical Systems, Inc..

What is the FDA product code for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

The FDA product code for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ is DXO.

Related Clinical Trials

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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: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) K193279Comet II Pressure GuidewireBoston Scientific Corporation

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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