FDA 510(k)

CELLO II Balloon Guide Catheter

Numéro K : K223275 · 2022-12-09

Date de décision2022-12-09

Code produitQJP

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

CELLO II Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Systems Corporation. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K223275. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CELLO II Balloon Guide Catheter?

CELLO II Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is Fuji Systems Corporation. The 510(k) number is K223275.

When did CELLO II Balloon Guide Catheter receive FDA 510(k) clearance?

CELLO II Balloon Guide Catheter received FDA 510(k) clearance on 2022-12-09, under 510(k) number K223275.

Who is the listed applicant for CELLO II Balloon Guide Catheter?

The FDA 510(k) record lists Fuji Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELLO II Balloon Guide Catheter?

The FDA product code for CELLO II Balloon Guide Catheter is QJP.

Essais cliniques associés

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Dispositifs connexes (Code : QJP)

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Source officielle

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