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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 K213451
Device Name Spartan MC 0165
Applicant
Spartan Micro
3167 Skyway Ct
Fremont,  CA  94539
Applicant Contact Gary Avedovech
Correspondent
Spartan Micro
3167 Skyway Ct
Fremont,  CA  94539
Correspondent Contact Gary Avedovech
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Codes
DQY   KRA  
Date Received10/26/2021
Decision Date 11/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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