FDA.reportPublic FDA data

PrimeWire Prestige Pressure Guide Wire 185cm JTIP

Primary DI
00845225001155
Brand
PrimeWire Prestige Pressure Guide Wire 185cm JTIP
Company
Volcarica S.R.L.
Model
8185J
Published
2016-08-22
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100930000PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300JVolcano Corporation2010-04-30DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225001155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225001155008452250011558452250011550845225001155

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip transducer, pressureA device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). 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
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
00845225002824Refinity Rotational Intravascular Ultrasound IVUS Catheter898002016-11-09
00845225002598Visions PV .035, 90 CM, US Digital IVUS Catheter812342016-08-23

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Primary DI, Brand, Company table
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04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
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10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
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