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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