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CELLO II Balloon Guide Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223275
510(k) Type
Traditional
Applicant
Fuji Systems Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
12/9/2022
Days to Decision
46 days
Submission Type
Summary

CELLO II Balloon Guide Catheter

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223275
510(k) Type
Traditional
Applicant
Fuji Systems Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
12/9/2022
Days to Decision
46 days
Submission Type
Summary