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FDA 510(k)

CELLO II Balloon Guide Catheter

K-Number: K223275 · 2022-12-09

ApplicantFuji Systems Corporation
Decision Date2022-12-09
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Fuji Systems Corporation. The 510(k) number is K223275.

When was CELLO II Balloon Guide Catheter approved by the FDA?

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

What company makes CELLO II Balloon Guide Catheter?

CELLO II Balloon Guide Catheter is manufactured by Fuji Systems Corporation.

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

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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