FDA.reportPublic FDA data

PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30139863463013986346PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC1N2026-01-011 School Street Morton PA US 19070

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2119121803331215K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)DXF2026-03-13
2119121858095637K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC2024-05-17
2119121527479469K221707SafeSept® Transseptal Guidewire (SS-140)DRC2022-09-14
2119121397922680K210328SafeSept Blunt NeedleDRC2021-03-05
2119121142439142K181031TSI Transseptal IntroducerDYB2018-10-26
2119121460317083K172950TSN Transseptal NeedleDRC2018-02-21
2119121255489889K172934Needle Free Transseptal CannulaDRC2018-02-16
2119122023776893K172893SafeSept Needle Free Transseptal GuidewireDRC2017-12-21
2119121867232542K170671SafeSept Transseptal GuidewireDRC2017-10-20
2119121450166671
2119122028304192

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRC72024-05-17
DXF12026-03-13
DYB12018-10-26

PMN#