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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 K260559
Device Name NHanceIT
Applicant
IMDS Operation B.V.
Ceintuurbaan Noord 150
Roden,  NL NL9301NZ¿
Applicant Contact Edwin Schulting
Correspondent
IMDS Operation B.V.
Ceintuurbaan Noord 150
Roden,  NL NL9301NZ¿
Correspondent Contact Edwin Schulting
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/19/2026
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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