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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K214025
Device Name PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
Applicant
Medos International Sarl
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Ivenette Guzman
Correspondent
CERENOVUS
6303 Blue Lagoon Drive, Suite 315
Miami,  FL  33126
Correspondent Contact Ivenette Guzman
Regulation Number870.1210
Classification Product Code
KRA  
Subsequent Product Codes
DQY   QJP  
Date Received12/22/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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