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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter for crossing total occlusions
510(k) Number K210664
Device Name DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Applicant
Ra Medical Systems, Inc.
2070 Las Palmas Drive
Carlsbad,  CA  92011
Applicant Contact Jami Miller
Correspondent
Ra Medical Systems, Inc.
2070 Las Palmas Drive
Carlsbad,  CA  92011
Correspondent Contact Jami Miller
Regulation Number870.1250
Classification Product Code
PDU  
Date Received03/05/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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