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Pressure Products Medical Device Manufacturing, LLC

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories3
Latest FDA decision2026-03-13
TypeNumberDevice NameCodeDateActions
510(k) K253799 SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)DXF2026-03-13 View
510(k) K241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC2024-05-17 View
510(k) K221707 SafeSept® Transseptal Guidewire (SS-140)DRC2022-09-14 View
510(k) K210328 SafeSept Blunt NeedleDRC2021-03-05 View
510(k) K181031 TSI Transseptal IntroducerDYB2018-10-26 View
510(k) K172950 TSN Transseptal NeedleDRC2018-02-21 View
510(k) K172934 Needle Free Transseptal CannulaDRC2018-02-16 View
510(k) K172893 SafeSept Needle Free Transseptal GuidewireDRC2017-12-21 View
510(k) K170671 SafeSept Transseptal GuidewireDRC2017-10-20 View
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