FDA.reportPublic FDA data

SOPHYSA

Primary DI
03760409447093
Brand
SOPHYSA
Company
SOPHYSA
Model
PSO-VTT
Device description
PRESSIO ICP & ICT MONITORING KIT, VENTRICULAR TUNNELING
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162108000Pressio 2 ICP Monitoring SystemSophysa SA2017-04-17GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760409447093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760409447093037604094470933760409447093

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral sensor catheter, short-termA flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.

Regulatory Flags#

DUNS number
262951353
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701813000023Catheter Extension CablePSO-EC302026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)PSO-MPM012026-10-27
03701813000054Catheter Extension CablePSO-EC302026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)PSO-MPM012026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsPSO-MCP012026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsPSO-MCP022026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsPSO-MCP032026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsPSO-MCP042026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsPSO-MCP052026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsPSO-MCP062026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsPSO-MCT2-A2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsPSO-MCT2-B2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsPSO-MCT2-C2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDAPSO-MCT2-E2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRAPSO-MCT2-F2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNPSO-MCT2-H2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmPSO-MPA012026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYPSO-MPA022026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data modulePSO-MPA042026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduPSO-MPA052026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701813000023Catheter Extension CableSOPHYSAGWM2026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03701813000054Catheter Extension CableSOPHYSAGWM2026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsSOPHYSAGWM2026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsSOPHYSAGWM2026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsSOPHYSAGWM2026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsSOPHYSAGWM2026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsSOPHYSAGWM2026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsSOPHYSAGWM2026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsSOPHYSAGWM2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsSOPHYSAGWM2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDASOPHYSAGWM2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRASOPHYSAGWM2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNSOPHYSAGWM2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmSOPHYSAGWM2026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYSOPHYSAGWM2026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data moduleSOPHYSAGWM2026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduSOPHYSAGWM2026-10-27
03760409441695PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW T6 & UMEC SERIES 8, 10,SOPHYSAGWM2026-10-27
03760409441701PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY PASSPORT 8, 12 & EPM 10, 12SOPHYSAGWM2026-10-27
03760409441718PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW N1, N12, N15, N17, N19,SOPHYSAGWM2026-10-27
03760409441725PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT, LIFE SCOPE VSOPHYSAGWM2026-10-27
03760409441732PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT with YJ-920PSOPHYSAGWM2026-10-27
03760409441749PRESSIO®3 - MULTI-PARAMETER NEUROMONITOR ICP, ICT, CPPSOPHYSAGWM2026-10-27
03760409442074PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409442081PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 14 pinsSOPHYSAGWM2026-10-27
03760409442098PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 12 pinsSOPHYSAGWM2026-10-27
03760409442104PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 11 pinsSOPHYSAGWM2026-10-27