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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 K241611
Device Name ShapeIT (SI014135)
Applicant
Imds Operations B.V.
Ceintuurbaan Noord 150
Roden,  NL NL9301NZ
Applicant Contact Edwin Schulting
Correspondent
Imds Operations B.V.
Ceintuurbaan Noord 150
Roden,  NL NL9301NZ
Correspondent Contact Edwin Schulting
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/05/2024
Decision Date 09/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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