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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
510(k) Number K231600
Device Name SENDERO Microcatheter
Applicant
Okami Medical, Inc.
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Jill Delsman
Correspondent
Okami Medical, Inc.
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Jill Delsman
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
DQO  
Date Received06/01/2023
Decision Date 11/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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