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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K200733
Device Name Opticross 35 15 MHz Peripheral Imaging Catheter
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Applicant Contact Jennifer L. Foley
Correspondent
Boston Scientific Corporation
3 Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Jennifer L. Foley
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Code
OBJ  
Date Received03/20/2020
Decision Date 04/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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