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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Septostomy
510(k) Number K182399
Device Name Park Blade Septostomy Catheter
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Rebecca Odulio
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Rebecca Odulio
Regulation Number870.5175
Classification Product Code
DXF  
Date Received09/04/2018
Decision Date 04/04/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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