CoroFlow Cardiovascular System

Primary DI
07350111070038
Brand
CoroFlow Cardiovascular System
Company
COROVENTIS Research AB
Model
12000WW
Device description
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.
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252238000CoroFlow Cardiovascular SystemCoroventis Research AB2025-10-24DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350111070038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350111070038073501110700387350111070038

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac catheterization laboratory computerA dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure525 Millimeter of Mercury795 Millimeter of Mercury
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure375 Millimeter of Mercury850 Millimeter of Mercury
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
352954840
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350111070755CoroFlow TouchPad120042025-11-23
07350111070694CoroFlow PPG Software12000-302025-11-03
07350111070663CoroFlow Upgrade kit12000-202022-03-01
07350111070014CoroFlow120002020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00198953107263MACGe Medical Systems Information Technologies, Inc.DQK2026-01-27
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19
00195278524089NAGE Healthcare Finland OyDQK2023-04-19