FDA.reportPublic FDA data

ALN Straight RS

Primary DI
03760017680103
Brand
ALN Straight RS
Company
A.L.N.
Model
FT.902010
Device description
The device is a Straight Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.
Published
2018-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163699000ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with HookAln Implants Chirurgicaux2017-09-08DTK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760017680103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760017680103037600176801033760017680103

GMDN Terms#

Term, Definition table
TermDefinition
Vena cava filter extraction/repositioning kitA collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
9999999999contact.us@aln2busa.com

Regulatory Flags#

DUNS number
272983094
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760017680004ALN Optional Vena Cava Filter - Femoral ApproachFF.0109952018-10-26
03760017680011ALN Optional Vena Cava Filter - Jugular ApproachFJ.1200962018-10-26
03760017680028ALN Optional Vena Cava Filter - Brachial ApproachFB.0105002018-10-26
03760017680042ALN Optional Vena Cava Filter - Femoral Approach with HookFF.HOOK2018-10-26
03760017680059ALN Optional Vena Cava Filter - Jugular Approach with HookFJ.HOOK2018-10-26
03760017680066ALN Optional Vena Cava Filter - Brachial Approach with HookFB.HOOK2018-10-26
03760017680110ALN Pre-Curved RSFT.902010/VS22018-10-26
03760017680127ALN 2in1RK-20102018-10-26

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
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
10827002529158Cook CelectWilliam Cook Europe ApSDTK2015-10-24