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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K220270
Device Name Aspirex Thrombectomy System
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Aaron Conovaloff
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Aaron Conovaloff
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
DQX  
Date Received01/31/2022
Decision Date 06/21/2022
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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