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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 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 2020-03-20 under 510(k) 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. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K193183.

When did ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

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 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 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)K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemK190473ACIST RXi System and Navvus II Catheter

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Related Devices (Code: OBJ)

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.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

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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