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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 K261281
Device Name CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
Applicant
Filmecc Co., Ltd.
3-99 Akatsuki-Cho
Seto-Shi,  JP 489-0071
Applicant Contact Hayato Tsuboi
Correspondent
Cardiomed Device Consultants
3618 Braverton St.
Edgewater,  MD  21037
Correspondent Contact Meagan Fagan
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/17/2026
Decision Date 09/03/2026
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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