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ENDOPHYS HOLDINGS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114939203011493920ENDOPHYS HOLDINGS, LLC1N2020-04-251601 ELM ST STE 1965 Dallas TX US 75201

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00852004007017Endophys Pressure Sensing Sheath Kit-6F - The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access.1-469-828-5119support@endophys.com
00852004007024Endophys Pressure Sensing Sheath Kit-6F - The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access.1-469-828-5119support@endophys.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1815981862802445K180620Endophys Pressure Sensing Sheath KitDYB2018-10-12
1815981866362502K173399Endophys Pressure Sensing Sheath Kit- 8FDYB2017-11-30
1815981247969606K160272Endophys Pressure Sensing Sheath KitDYB2016-03-04
1815981268735048K141615ENDOPHYS BLOOD PRESSURE MONITORDSK2015-01-07
1815981157405674K141275ENDOPHYS PRESSURE SENSING SHEATH KITDYB2015-01-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB42018-10-12
DSK12015-01-07

PMN#

GUDID#