FDA.reportPublic FDA data

Option Elite Retrievable Vena Cava Filter

Primary DI
00886333222346
Brand
Option Elite Retrievable Vena Cava Filter
Company
ARGON MEDICAL DEVICES, INC.
Model
352506100E
Catalog number
352506100E
Device description
Option Elite Retrievable Vena Cava Filter Suitable for Antecubital or Popliteal Delivery
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00886333222346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886333222346008863332223468863332223460886333222346

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Away from Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333210893Guidewire3951263951262016-09-21
00886333001408Skin Fix8025000008025000002022-07-14
00886333217618Skater™ Fix8025000018025000012022-07-14
00886333226320Co-Axial Introducer NeedleMCXS1620BXMCXS1620BX2022-07-21
00886333000005SKATER™ Drainage Catheter751106025E7511060252022-07-11
00886333000012SKATER™ Drainage Catheter751106035E7511060352022-07-12
00886333000029SKATER™ Drainage Catheter751107025E7511070252022-07-12
00886333000036SKATER™ Drainage Catheter751107035E7511070352022-07-11
00886333000043SKATER™ Drainage Catheter751108025E7511080252022-07-11
00886333000067SKATER™ Drainage Catheter751110025E7511100252022-07-12
00886333000074SKATER™ Drainage Catheter751110035E7511100352022-07-12
00886333000081SKATER™ Drainage Catheter751112025E7511120252022-07-13
00886333000098SKATER™ Drainage Catheter751112035E7511120352022-07-12
00886333000104SKATER™ Drainage Catheter751114025E7511140252022-07-12
00886333000111SKATER™ Drainage Catheter755106025E7551060252022-07-13
00886333000128SKATER™ Drainage Catheter755106035E7551060352022-07-12
00886333000135SKATER™ Drainage Catheter755107025E7551070252022-07-13
00886333000142SKATER™ Drainage Catheter755107035E7551070352022-07-12
00886333000159SKATER™ Drainage Catheter755108025E7551080252022-07-12
00886333000166SKATER™ Drainage Catheter 755108035E7551080352022-07-13

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
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
10827002529158Cook CelectWilliam Cook Europe ApSDTK2015-10-24