Occlutech International AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30126135413012613541Occlutech International AB1N2026-01-01Landskronavagen 2 Helsingborg Skane SE 25232

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
07340175601941Occlutech ASD Occluder Procedure Pack - The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.877-836-2228xx@xx.xx
07340175601958Occlutech ASD Occluder Procedure Pack - The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.877-836-2228xx@xx.xx
07340175601965Occlutech ASD Occluder Procedure Pack - The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.877-836-2228xx@xx.xx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3250771433869333P200032Occlutech® ASD Occluder and Occlutech® Pistol PusherOZG2023-12-29

GUDID#