FDA.reportPublic FDA data

ComboMap Pressure and Flow System

Primary DI
00845225010874
Brand
ComboMap Pressure and Flow System
Company
VOLCANO CORPORATION
Model
6800
Catalog number
802745001
Published
2016-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041134000COMBOMAP PRESSURE AND FLOW SYSTEMVolcano Therapeutics, Inc.2004-06-02OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225010874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225010874008452250108748452250108740845225010874

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular haemodynamic monitoring systemAn assembly of devices used for the continuous in vivo measurement and display of blood pressure and blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically includes a vascular pressure/flow measuring guidewire equipped with transducers/sensors at its working end, a computer with a touchscreen monitor to display the readings, and alarms; it may also include an electrocardiograph (ECG) input, a printer, and a remote control. The system is used to obtain haemodynamic information for the diagnosis and treatment of blood vessel disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
135179237
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225012663CORE M2 Vascular System400-0100.17400-0100.172017-06-06
00845225012731SmartMap Pressure System800573001-ROHS800573001-ROHS2016-09-19
00184360000327R-1008045470018045470012016-09-12
20845225012681SpinVision STERILE EQUIPEMENT COVER891BG2016-09-08
20845225012698DIGITAL IVUS STERILE EQUIPEMENT COVER5902VC2017-03-02
00845225002527Crux® Vena Cava FIlter, Femoral70242015-09-17
00845225002534Crux® Vena Cava FIlter, Jugular70252015-09-17
00845225010195S5 IMAGING SYSTEM P/N 8073000018073000012016-09-22
00845225010218s5i Imaging System8074000012016-09-12
00845225012472CORE FM SYSTEM400-0100.112016-09-12
00845225012670CORE Series Precision Guided Therapy SystemS18081AA2016-09-12
00184360000167FloWire Doppler Guide Wire XT 175cm 014 JTIP1403J2016-08-24
00184360000198FloWire Doppler Guide Wire XT 300cm 014 ST14132016-08-24
00184360000204FloWire Doppler Guide Wire XT 300cm 014 JTIP1413J2016-08-24
00184360000334ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor95152016-08-24
00184360000341ComboWire Pressure/Flow Guide Wire XT95002016-08-24
00184360000686s5i Imaging System Workstation 8074010012016-09-12
00845225012656CORE FM CART410-0100.112016-09-12
00845225001261LoMap8094850012016-09-12
00845225010096Connection Box411-0100.012016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.IYO2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.IYO2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.IYO2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.IYO2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.IYO2026-05-28
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05