FDA 510(k)

ACIST RXi Système et Navvus II Cathéter

Numéro K : K190473 · 2019-09-13

Date de décision2019-09-13

Code produitOBI

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ACIST RXi System and Navvus II 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 2019-09-13 under 510(k) number K190473. The device is classified under product code OBI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACIST RXi System and Navvus II Catheter?

ACIST RXi System and Navvus II Catheter is a medical device that received FDA 510(k) clearance on 2019-09-13. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K190473.

When did ACIST RXi System and Navvus II Catheter receive FDA 510(k) clearance?

ACIST RXi System and Navvus II Catheter received FDA 510(k) clearance on 2019-09-13, under 510(k) number K190473.

Who is the listed applicant for ACIST RXi System and Navvus II 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 RXi System and Navvus II Catheter?

The FDA product code for ACIST RXi System and Navvus II Catheter is OBI.

Essais cliniques associés

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

K262115VueJect® Ultrasound Enhancing Agent Delivery System K252653ACIST Pro Système diagnostique (019304); Unité de traitement Montage lit; Module AngioTouch; ACIST Pro Chariot; Câble transducteur unique; Câble transducteur triple 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 Système (016616); ACIST Navvus II Cathéter (016675_)K203004ACIST CVi1 Système de distribution de contraste, ACIST CVi Système de distribution de contraste K193183ACIST HDi Système, ACIST Kodama Cathéter d'échographie intravasculaire

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Source officielle

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