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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 K220683
Device Name INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Sindokht (Sisi) Soltanzadeh
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Sindokht (Sisi) Soltanzadeh
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
QEX  
Date Received03/08/2022
Decision Date 10/04/2022
Decision SE - With Limitations (SESU)
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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