FDA.reportPublic FDA data

Crux® Vena Cava FIlter, Femoral

Primary DI
00845225002527
Brand
Crux® Vena Cava FIlter, Femoral
Company
VOLCANO CORPORATION
Model
7024
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DTKFilter, Intravascular, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTKFilter, Intravascular, CardiovascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845225002527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845225002527008452250025278452250025270845225002527

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter, temporary/permanentA vascular device intended to be percutaneously implanted in the inferior vena cava (IVC) to prevent pulmonary embolism (PE); it can be retrieved before a threshold period or remain as a permanent implant after the period. It achieves its unconstrained diameter upon deployment in the IVC and imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. It is designed for blood clot capture while maintaining caval patency. It is made of metal alloys [e.g., stainless steel, titanium (Ti), nickel-titanium alloy (Nitinol)] and is available in various self-expanding designs (e.g., conical, basket). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
135179237
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
00845225012663CORE M2 Vascular System400-0100.17400-0100.172017-06-06
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
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
00886333217519Option Elite Retrievable Vena Cava FilterARGON MEDICAL DEVICES, INC.DTK2019-07-26
03760017680004ALN Optional Vena Cava Filter - Femoral ApproachA.L.N.DTK2018-10-26
03760017680011ALN Optional Vena Cava Filter - Jugular ApproachA.L.N.DTK2018-10-26
03760017680028ALN Optional Vena Cava Filter - Brachial ApproachA.L.N.DTK2018-10-26
03760017680042ALN Optional Vena Cava Filter - Femoral Approach with HookA.L.N.DTK2018-10-26
03760017680059ALN Optional Vena Cava Filter - Jugular Approach with HookA.L.N.DTK2018-10-26
03760017680066ALN Optional Vena Cava Filter - Brachial Approach with HookA.L.N.DTK2018-10-26
03760017680103ALN Straight RSA.L.N.DTK2018-10-26
03760017680110ALN Pre-Curved RSA.L.N.DTK2018-10-26
03760017680127ALN 2in1A.L.N.DTK2018-10-26
05391529380069Sentry IVC FilterNOVATE MEDICAL LIMITEDDTK2018-09-27
05391529380076Sentry IVC FilterNOVATE MEDICAL LIMITEDDTK2018-09-27
20705032009369OPTEASECORDIS CORPORATIONDTK2017-09-18
04046964332333VENA TECHB. BRAUN MEDICAL INC.DTK2017-01-18
00886333222346Option Elite Retrievable Vena Cava FilterARGON MEDICAL DEVICES, INC.DTK2016-09-23
00886333217151Option Elite Retrievable Vena Cava Filter SystemARGON MEDICAL DEVICES, INC.DTK2016-09-21
04027478130318VENA TECH™B BRAUN INTERVENTIONAL SYSTEMS, INCDTK2016-08-09
04027478130752VENA TECHB BRAUN INTERVENTIONAL SYSTEMS, INCDTK2016-03-17
08714729050650Entry KitBOSTON SCIENTIFIC CORPORATIONDTK2016-01-29
10827002355801Cook CelectWilliam Cook Europe ApSDTK2015-12-07
00857141005001OptionELITE Vena Cava FilterRex Medical LLPDTK2015-12-07
00857141005018OptionELITE Vena Cava Filter, 100cmRex Medical LLPDTK2015-12-07
10827002037660Gunther TulipWilliam Cook Europe ApSDTK2015-10-24
10827002037677Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002213606Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002330167Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002330174Gunther TulipCOOK INCORPORATEDDTK2015-10-24
10827002355900Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002529097Cook CelectWilliam Cook Europe ApSDTK2015-10-24
10827002529141Cook CelectWilliam Cook Europe ApSDTK2015-10-24