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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 K231629
Device Name 091 Balloon Guide Catheter
Applicant
Eosolutions, Corp.
19700 Sterling Rd., Suite 1
Pembroke Pines,  FL  33332
Applicant Contact Marc Litzenberg
Correspondent
Inneuroco, Inc.
19700 Sterling Rd., Suite 1
Pembroke Pines,  FL  33332
Correspondent Contact Garry Koroshec
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received06/05/2023
Decision Date 10/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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