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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K193071
Device Name Bashir Plus 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 Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received11/04/2019
Decision Date 12/17/2019
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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