FDA 510(k)

ACIST CVI1 Kontrastmittel-Verabreichungssystem, A1000 Spritzenkit, A1000V Spritzenkit, BT2000 Manifoldkit, BT2000 Manifoldkit, AngioTouch Handcontrollerkit

K-Nummer: K191060 · 2019-07-18

AntragstellerAcist Medical Systems, Inc.

Entscheidungsdatum2019-07-18

ProduktcodeDXT

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit 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 2019-07-18 under 510(k) number K191060. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K191060.

When did ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit receive FDA 510(k) clearance?

ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit received FDA 510(k) clearance on 2019-07-18, under 510(k) number K191060.

Who is the listed applicant for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

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 CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit?

The FDA product code for ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit is DXT.

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Weitere Einträge mit Acist Medical Systems, Inc. als Antragsteller

K262115VueJect® Ultrasound Enhancing Agent Delivery System K252653ACIST Pro Diagnosesystem (019304); Verarbeitungseinheit Bettmontage; AngioTouch Modul; ACIST Pro Wagen; Einzelsensorkabel; Dreibandsensorkabel K252638VeraPro 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 Katheter (016675_)K203004ACIST CVi1 Kontrastmittel-Verabreichungssystem, ACIST CVi Kontrastmittel-Verabreichungssystem K193183ACIST HDi System, ACIST Kodama Intravaskuläres Ultraschallkatheter

Alle 12 Geräte anzeigen →

Verwandte Geräte (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro 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)Acist Medical Systems, Inc.K252653ACIST Pro Diagnosesystem (019304); Verarbeitungseinheit Bettmontage; AngioTouch Modul; ACIST Pro Wagen; Einzelsensorkabel; DreibandsensorkabelAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

Offizielle Quelle

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