FDA 510(k)

ACIST Kodama Cathéter d'échographie intravasculaire, ACIST HDi Système

Numéro K : K191175 · 2019-06-27

Date de décision2019-06-27

Code produitOBJ

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi 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 2019-06-27 under 510(k) number K191175. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is a medical device that received FDA 510(k) clearance on 2019-06-27. The listed applicant is Acist Medical Systems, Inc.. The 510(k) number is K191175.

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

ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System received FDA 510(k) clearance on 2019-06-27, under 510(k) number K191175.

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

The FDA product code for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System is OBJ.

Essais cliniques associés

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

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Dispositifs connexes (Code : OBJ)

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Source officielle

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