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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 K220716
Device Name Spartan SC 069
Applicant
Spartan Micro, Inc.
Costa Mesa,  CA  92626
Applicant Contact Gary Avedovech
Correspondent
Spartan Micro
3184 Airway Ave., Suite C
Costa Mesa,  CA  92626
Correspondent Contact Gary Avedovech
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received03/11/2022
Decision Date 05/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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