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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, thrombus retriever
510(k) Number K183043
Device Name 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
Applicant
Imperative Care Inc.
1359 Dell Avenue
Campbell,  CA  95008
Applicant Contact Jake Wolenberg
Correspondent
Imperative Care Inc.
1359 Dell Avenue
Campbell,  CA  95008
Correspondent Contact Jake Wolenberg
Regulation Number870.1250
Classification Product Code
NRY  
Date Received11/02/2018
Decision Date 04/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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