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COROVENTIS RESEARCH AB

Matched from indexed company URL: COROVENTIS Research AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30178452863017845286COROVENTIS RESEARCH AB1N2026-01-01Ulls vag 29A Uppsala SE 75651

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2836521525675366K252238CoroFlow Cardiovascular SystemDQK2025-10-24
2836521534083401K201881CoroFlow Cardiovascular SystemDQK2020-11-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQK22025-10-24

PMN#

GUDID#

CoroFlow Cardiovascular System - CoroFlow Cardiovascular System is a system used to collect, calculate, present and store physiological parameters measured by Abbott Medical’s PressureWire X and Wi-box. Parameters include Pa, Pd, FFR, Pd/Pa, RFR, CFR, IMR, RRR, Absolute Flow, Absolute Resistance, dP/dt, PPG, intravascular temperature. CoroFlow Cardiovascular System is installed on a personal computer and receives measurement data wirelessly via the CoroHub Receiver. Information is displayed on the computers screen which can optionally be slaved to a monitor inside the coronary cathlab.

COROVENTIS Research AB

2025-11-23