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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K253667
Device Name Accoat Guide Wire
Applicant
Sp Medical A/S
Møllevej 1
Karise,  DK DK-4653
Applicant Contact Philip Davenport
Correspondent
Sp Medical A/S
Møllevej 1
Karise,  DK DK-4653
Correspondent Contact Philip Davenport
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/21/2025
Decision Date 07/14/2026
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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