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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K173680
Device Name Sapphire II PRO
Applicant
Orbusneich Medical Trading, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309
Applicant Contact John Pazienza
Correspondent
Orbusneich Medical Trading, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309
Correspondent Contact John Pazienza
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/01/2017
Decision Date 03/01/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT03052530
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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