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Pressure Products Medical Device Manufacturing, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235;March 13, 2026
K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)May 17, 2024
K221707SafeSept® Transseptal Guidewire (SS-140)September 14, 2022
K210328SafeSept Blunt NeedleMarch 5, 2021
K181031TSI Transseptal IntroducerOctober 26, 2018
K172950TSN Transseptal NeedleFebruary 21, 2018
K172934Needle Free Transseptal CannulaFebruary 16, 2018
K172893SafeSept Needle Free Transseptal GuidewireDecember 21, 2017
K170671SafeSept Transseptal GuidewireOctober 20, 2017