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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 the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-07-17 under 510(k) 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. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K233904.

When did ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ receive FDA 510(k) clearance?

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

Who is the listed applicant for ACIST RXi System (016616); ACIST Navvus II Catheter (016675_?

The FDA 510(k) record lists Acist Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Acist Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262115VueJect® Ultrasound Enhancing Agent Delivery SystemK252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableK252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemK193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterK190473ACIST RXi System and Navvus II Catheter

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Related Devices (Code: DXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.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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