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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K171193
Device Name Certa Catheter
Applicant
Ferrosan Medical Devices Sp. Z.O.O.
Koksowa 3
Szczecin,  PL 70-031
Applicant Contact Elzbieta Porebska-Guillemant
Correspondent
Ferrosan Medical Devices Sp. Zo.O. C/O Promedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.5120
Classification Product Code
BSO  
Date Received04/24/2017
Decision Date 12/18/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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