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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K191419
Device Name Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
Applicant
Rex Medical, L.P.
555 East North Lane, Suite 5035
Conshohocken,  PA  19428
Applicant Contact Colin Valentis
Correspondent
Rex Medical, L.P.
555 East North Lane, Suite 5035
Conshohocken,  PA  19428
Correspondent Contact Colin Valentis
Regulation Number870.4875
Classification Product Code
MCW  
Date Received05/28/2019
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02961894
Reviewed by Third Party No
Combination Product No
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