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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 K242644
Device Name SENDERO MAX Delivery Catheter
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  
Date Received09/03/2024
Decision Date 12/20/2024
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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