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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, continuous flush
510(k) Number K192598
Device Name Bashir S-B Endovascular Catheter
Applicant
Thrombolex, Inc.
75 New Britain Dr.
new britain,  PA  18901
Applicant Contact amy katsikis
Correspondent
Eminence Clinical Research Inc.
5 Lake Como Ct.
greenville,  SC  29609
Correspondent Contact diane horwitz
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/20/2019
Decision Date 10/18/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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