FDA 510(k)

ACIST CVi1 Système de distribution de contraste, ACIST CVi Système de distribution de contraste

Numéro K : K203004 · 2020-12-17

Date de décision2020-12-17

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System 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 2020-12-17 under 510(k) number K203004. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is a medical device that received FDA 510(k) clearance on 2020-12-17. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K203004.

When did ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System receive FDA 510(k) clearance?

ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System received FDA 510(k) clearance on 2020-12-17, under 510(k) number K203004.

Who is the listed applicant for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System?

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, ACIST CVi Contrast Delivery System?

The FDA product code for ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System is DXT.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Acist Medical Systems, Inc. en tant que demandeur

K262115VueJect® Ultrasound Enhancing Agent Delivery System 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)K252653ACIST Pro Système diagnostique (019304); Unité de traitement Montage lit; Module AngioTouch; ACIST Pro Chariot; Câble transducteur unique; Câble transducteur triple K233904ACIST RXi Système (016616); ACIST Navvus II Cathéter (016675_)K193183ACIST HDi Système, ACIST Kodama Cathéter d'échographie intravasculaire K190473ACIST RXi Système et Navvus II Cathéter

Voir tous les 12 dispositifs →

Dispositifs connexes (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 Système diagnostique (019304); Unité de traitement Montage lit; Module AngioTouch; ACIST Pro Chariot; Câble transducteur unique; Câble transducteur tripleAcist 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.