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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K261610
Device Name Verge™ Microcatheter
Applicant
Instylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford,  MA  01730
Applicant Contact Easwar Prabakaran
Correspondent
Instylla, Inc.
201 Burlington Rd.
North Bldg.
Bedford,  MA  01730
Correspondent Contact Easwar Prabakaran
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/14/2026
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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