FDA.reportPublic FDA data

R-100

Primary DI
00184360000327
Brand
R-100
Company
VOLCANO CORPORATION
Model
804547001
Catalog number
804547001
Device description
R-100 Pullback Device
Published
2016-09-12
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
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962293000ENDOSONICS AUTOMATIC PULL BACK DEVICEEndosonics Corp.1996-09-16ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00184360000327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00184360000327001843600003271843600003270184360000327

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter extractor, reusableA non-sterile, battery-powered, electronic device intended to slowly retract (pull back) an intravascular ultrasound imaging catheter from a coronary or peripheral artery at a controlled rate using a motor combined with an extraction mechanism. This device is used in the catheterization laboratory during intravascular assessment, e.g., for the reconstruction of a two dimensional, sagittal ultrasonic diagnostic image as the catheter is slowly extracted. Pullback lengths are around 13 cm. This device is not sterilizable and must therefore be enclosed in a sterile barrier (a bag or pouch). This is a reusable device.

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
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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

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