FDA.reportPublic FDA data

Occlutech ASD Occluder

Primary DI
04260182521571
Brand
Occlutech ASD Occluder
Company
Occlutech GmbH
Model
37ASD10
Catalog number
37ASD10
Device description
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 is packaged with its compatible Occlutech Pistol Pusher (OPP), Instructions for Use (IFU) and Patient Implant Card.
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZGTranscatheter Septal Occluder (Atrial)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZGTranscatheter Septal Occluder (Atrial)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P200032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P200032000Occlutech® ASD Occluder and Occlutech® Pistol PusherOcclutech Holding AG2023-12-29OZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260182521571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260182521571042601825215714260182521571

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac defect occluderAn implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Dry and Away from Sunlight
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-836-2228xx@xx.xx

Regulatory Flags#

DUNS number
312548545
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260182521540Occlutech ASD Occluder37ASD0637ASD062024-03-05
04260182521557Occlutech ASD Occluder37ASD0737ASD072024-03-05
04260182521564Occlutech ASD Occluder37ASD0937ASD092024-03-05
04260182521588Occlutech ASD Occluder37ASD1237ASD122024-03-05
04260182521595Occlutech ASD Occluder37ASD1337ASD132024-03-05
04260182521601Occlutech ASD Occluder37ASD1537ASD152024-03-05
04260182521618Occlutech ASD Occluder37ASD1637ASD162024-03-05
04260182521625Occlutech ASD Occluder37ASD1837ASD182024-03-05
04260182521632Occlutech ASD Occluder37ASD1937ASD192024-03-05
04260182521649Occlutech ASD Occluder37ASD2137ASD212024-03-05
04260182521656Occlutech ASD Occluder37ASD2437ASD242024-03-05
04260182521663Occlutech ASD Occluder37ASD2737ASD272024-03-05
04260182521670Occlutech ASD Occluder37ASD3037ASD302024-03-05
04260182521687Occlutech ASD Occluder37ASD3337ASD332024-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260182521540Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521557Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521564Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521588Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521595Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521601Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521618Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521625Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521632Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521649Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521656Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521663Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521670Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
04260182521687Occlutech ASD OccluderOcclutech GmbHOZG2024-03-05
07340175601941Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601958Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601965Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601972Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601989Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175601996Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602009Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602016Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602023Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602030Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602047Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602054Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602061Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602078Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
07340175602085Occlutech ASD Occluder Procedure PackOcclutech International ABOZG2024-03-05
08683463400161Occlutech Pistol PusherOCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETIOZG2024-03-05