ComboWire Pressure/Flow Guide Wire XT

GUDID 00184360000341

VOLCANO CORPORATION

Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire Intravascular haemodynamic monitoring system guidewire
Primary Device ID00184360000341
NIH Device Record Keybc5f5cd2-aac1-4852-a40c-63ccebd10b49
Commercial Distribution StatusIn Commercial Distribution
Brand NameComboWire Pressure/Flow Guide Wire XT
Version Model Number9500
Company DUNS135179237
Company NameVOLCANO CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100184360000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-24

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