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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K241042
Device Name SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
Applicant
Pressure Products Medical Device Manufacturing, LLC
1 School St.
Morton,  PA  19070
Applicant Contact Andrew Armour
Correspondent
Pressure Products Medical Device Manufacturing, LLC
1 School St.
Morton,  PA  19070
Correspondent Contact Andrew Armour
Regulation Number870.1390
Classification Product Code
DRC  
Date Received04/17/2024
Decision Date 05/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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