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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 K253799
Device Name SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
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 Number870.5175
Classification Product Code
DXF  
Date Received11/28/2025
Decision Date 03/13/2026
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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