FDA.reportPublic FDA data

Refinity Rotational Intravascular Ultrasound IVUS Catheter

Primary DI
00845225002824
Brand
Refinity Rotational Intravascular Ultrasound IVUS Catheter
Company
Volcarica S.R.L.
Model
89800
Published
2016-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160583000REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation2016-10-26OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002824008452250028248452250028240845225002824

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, single-useA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
853202646
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845225001100PrimeWire Prestige Plus Pressure Guide Wire 185cm ST91852016-08-22
00845225001117PrimeWire Prestige Plus Pressure Guide Wire 185cm JTIP9185J2016-08-22
00845225001124PrimeWire Prestige Plus Pressure Guide Wire 300cm ST93002016-08-22
00845225001131PrimeWire Prestige Plus Pressure Guide Wire 300cm JTIP9300J2016-08-22
00845225001148PrimeWire Prestige Pressure Guide Wire 185cm ST81852016-08-23
00845225001155PrimeWire Prestige Pressure Guide Wire 185cm JTIP8185J2016-08-22
00845225001162PrimeWire Prestige Pressure Guide Wire 300cm ST83002016-08-22
00845225001179PrimeWire Prestige Pressure Guide Wire 300cm JTIP8300J2016-08-23
00845225002435Verrata Pressure Guide Wire 185cm101852016-08-22
00845225002442Verrata Pressure Guide Wire 185cm JTIP10185J2016-08-22
00845225002459Verrata Pressure Guide Wire 300cm103002016-08-22
00845225002466Verrata Pressure Guide Wire 300cm JTIP10300J2016-08-22
00845225002598Visions PV .035, 90 CM, US Digital IVUS Catheter812342016-08-23

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