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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 K162209
Device Name Sapphire NC Plus
Applicant
Orbusneich Medical, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309
Applicant Contact John D. Pazienza
Correspondent
Orbusneich Medical, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309
Correspondent Contact John D. Pazienza
Regulation Number870.5100
Classification Product Code
LOX  
Date Received08/05/2016
Decision Date 10/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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