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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K182713
Device Name Scoreflex PTA Scoring Balloon Catheter
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 Number870.1250
Classification Product Code
PNO  
Subsequent Product Code
LIT  
Date Received09/27/2018
Decision Date 06/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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