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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
510(k) Number K182360
Device Name Teleport Microcatheter
Applicant
Orbusneich Medical Trading, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33060
Applicant Contact John Pazienza
Correspondent
Orbusneich Medical Trading, Inc.
5363 NW 35th Ave.
Fort Lauderdale,  FL  33060
Correspondent Contact John Pazienza
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/30/2018
Decision Date 11/09/2018
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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