Medical Device Manufacturer · US , Morton , PA

Pressure Products Medical Device Manufacturing, LLC - FDA 510(k) Clea...

9 submissions · 9 cleared · Since 2017

Recent clearances: SafeSept RF Transseptal Guidewire (SSRF132, SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198), SafeSept® Transseptal Guidewire (SS-140)

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Pressure Products Medical Device Manufacturing, LLC Cardiovascular ✕

9 devices
1-9 of 9
Cleared Mar 13, 2026
SafeSept RF Transseptal Guidewire (SSRF132
K253799 · DXF
Cardiovascular · 105d
Cleared May 17, 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · DRC
Cardiovascular · 30d
Cleared Sep 14, 2022
SafeSept® Transseptal Guidewire (SS-140)
K221707 · DRC
Cardiovascular · 93d
Cleared Mar 05, 2021
SafeSept Blunt Needle
K210328 · DRC
Cardiovascular · 29d
Cleared Oct 26, 2018
TSI Transseptal Introducer
K181031 · DYB
Cardiovascular · 191d
Cleared Feb 21, 2018
TSN Transseptal Needle
K172950 · DRC
Cardiovascular · 148d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934 · DRC
Cardiovascular · 144d
Cleared Dec 21, 2017
SafeSept Needle Free Transseptal Guidewire
K172893 · DRC
Cardiovascular · 90d
Cleared Oct 20, 2017
SafeSept Transseptal Guidewire
K170671 · DRC
Cardiovascular · 228d
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