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…
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.
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for CoroFlow Cardiovascular System | Listed by | Coroventis Research AB, Sweden |
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K252238 |
| Record published | 2025-11-23 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 525 to 795 Millimeter of Mercury; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Storage environment atmospheric pressure 375 to 850 Millimeter of Mercury; Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 70 °C |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.