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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ultrasound, Intravascular
510(k) Number K252945
Device Name Novasight Hybrid System
Applicant
Conavi Medical, Inc.
293 Lesmill Rd.
Toronto,  CA M3B2V1
Applicant Contact David Zhang
Correspondent
Avania
250 Carlaw Ave.
Suite 108
Toronto,  CA M4M 3L1
Correspondent Contact Sophia Farcas
Regulation Number870.1200
Classification Product Code
OBJ  
Subsequent Product Codes
IYO   NQQ  
Date Received09/15/2025
Decision Date 04/17/2026
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		 Yes
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