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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 K231653
Device Name BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
Applicant
Thrombolex, Inc.
75 New Britain Dr.
New Britain,  PA  18901
Applicant Contact Amy Katsikas
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 Received06/06/2023
Decision Date 07/03/2023
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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