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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Neurovasculature
510(k) Number K223275
Device Name CELLO II Balloon Guide Catheter
Applicant
Fuji Systems Corporation
200-2, Aza-Ohira, Odakura, Nishigo
Nishi Shirakawa Gun,  JP 961-8061
Applicant Contact Yoshiyuki Suzuki
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received10/24/2022
Decision Date 12/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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