Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07247864Balloon Guide Catheter Combined With Filter Protection for Carotid Artery StentingRECRUITINGNCT07576790Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)NOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Related Devices (Code: QJP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.

↑