A.L.N.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070806173007080617ALN S.A.R.L.1N2026-01-01589 CHEMIN DU NIEL BORMES LES MIMOSAS Var FR 83230
30072246483007224648ALN INTERNATIONAL INC.1Y2026-01-017320 NW 12th St Ste 104 Miami FL US 33126

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03760017680004ALN Optional Vena Cava Filter - Femoral Approach - The device is an Optional Vena Cava Filter - Femoral Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680011ALN Optional Vena Cava Filter - Jugular Approach - The device is an Optional Vena Cava Filter - Jugular Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680028ALN Optional Vena Cava Filter - Brachial Approach - The device is an Optional Vena Cava Filter - Brachial Kit. It consists of a nine legs 316L stainless steel filter supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680042ALN Optional Vena Cava Filter - Femoral Approach with Hook - The device is an Optional Vena Cava Filter - Femoral Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680059ALN Optional Vena Cava Filter - Jugular Approach with Hook - The device is an Optional Vena Cava Filter - Jugular Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680066ALN Optional Vena Cava Filter - Brachial Approach with Hook - The device is an Optional Vena Cava Filter - Brachial Kit with Hook. It consists of a nine legs 316L stainless steel filter with a hook at the apex supplied with a delivery kit including a puncture needle, a J guidewire, a 7F introduction sheath, a dilatator and a pusher catheter. The filter is pre-packaged in a filter holder designed to facilitate the insertion of the filter in the introducer sheath.9999999999contact.us@aln2busa.com
03760017680103ALN Straight RS - 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.9999999999contact.us@aln2busa.com
03760017680110ALN Pre-Curved RS - The device is a Pre-curved 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.9999999999contact.us@aln2busa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
925901348196164K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)DTK2024-06-26
925901062687847K163699ALN 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 HookDTK2017-09-08
925901543941019K113124ALN OPTIONAL VANA CAVA FILTERDTK2012-11-09
925901669916780K070514ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIODTK2008-01-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTK42024-06-26

NDC#

Onpattro

Alnylam Pharmaceuticals, Inc.

patisiran

GIVLAARI

Alnylam Pharmaceuticals, Inc.

givosiran sodium

OXLUMO

Alnylam Pharmaceuticals, Inc.

lumasiran

AMVUTTRA

Alnylam Pharmaceuticals, Inc.

VUTRISIRAN

PMN#

Applications#

GUDID#