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FDA 510(k) Applications Submitted by Andrew Armour
FDA 510(k) Number
Submission Date
Device Name
Applicant
K170671
03/06/2017
SafeSept Transseptal Guidewire
Pressure Products Medical Device Manufacturing LLC
K181031
04/18/2018
TSI Transseptal Introducer
Pressure Products Medical Device Manufacturing LLC
K221707
06/13/2022
SafeSept« Transseptal Guidewire (SS-140)
Pressure Products Medical Device Manufacturing LLC.
K172893
09/22/2017
SafeSept Needle Free Transseptal Guidewire
Pressure Products Medical Device Manufacturing LLC
K172934
09/25/2017
Needle Free Transseptal Cannula
Pressure Products Medical Device Manufacturing LLC
K172950
09/26/2017
TSN Transseptal Needle
Pressure Products Medical Device Manufacturing LLC
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