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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 K262277
Device Name 70 NeuGlide Catheter
Applicant
Piraeus Medical, Inc.
7351 Kirkwood Ln. N, Suite 116
Maple Grove,  MN  55369
Applicant Contact Sarah Kabanuk
Correspondent
Piraeus Medical
7351 Kirkwood Lane North, Suite 116
Maple Grove,  MN  55369
Correspondent Contact Sarah Kabanuk
Regulation Number870.1250
Classification Product Code
QJP  
Subsequent Product Code
DQY  
Date Received07/06/2026
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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