FDA.reportPublic FDA data

CORE M2 Vascular System

Primary DI
00845225012663
Brand
CORE M2 Vascular System
Company
VOLCANO CORPORATION
Model
400-0100.17
Catalog number
400-0100.17
Published
2017-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170385000CORE M2 Vascular SystemVolcano Corporation2017-04-06IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225012663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225012663008452250126638452250126630845225012663

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
135179237
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
00845225012731SmartMap Pressure System800573001-ROHS800573001-ROHS2016-09-19
00184360000327R-1008045470018045470012016-09-12
00845225010874ComboMap Pressure and Flow System 68008027450012016-12-08
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
04048675729631ECG trunk cable 12-lead SinglePin Vista300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675729655Adapter cable Masimo/ Nellcor SpO2 Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
04048675746768Temp adapter Jack Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.DSA2026-07-13
00860013043605EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
00860013043612EdgeLife TechnologiesEdge Life Technologies, LLCIYO2026-07-10
06938396440008SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2026-07-10
06931973403939CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435398CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435404CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973435411CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973439082CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457116CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457123CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457130CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457147CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457154CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457161CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457185CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457192CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457208CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457215CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
06931973457246CaremedShenzhen Caremed Medical Technology Co., Ltd.DSA2026-07-09
08720938410284QMAPPFysicon B.V.DSA2026-06-26
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.IYO2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.IYO2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.IYO2026-06-24
G662ME590030M31MaguireMaguire Enterprises, Inc.DSA2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.IYO2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.IYO2026-06-22