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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 K232574
Device Name VASSALLO GT Crossing14
Applicant
Filmec Co. Ltd.
1703 Wakita-cho, Moriyama-ku
Hagoya-shi,  JP 463-0024
Applicant Contact Toshiya Osawa
Correspondent
CordioMed Device Consultants
1783 Forest Drive Suite 254
Annapolis,  MD  21401
Correspondent Contact Meagan Fagan
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/25/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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