Identity
- Trade Name
- Occlutech ASD Occluder FDA UDI
- Generic Name
- Cardiac defect occluder FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 37ASD06 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 37ASD06 FDA UDI
- Primary DI / UDI-DI
- 04260182521540 FDA UDI
- PMA Number
- P200032 FDA UDI
- FDA Product Code
- OZG FDA UDI
- GMDN Term
- Cardiac defect occluder FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Category: Cardiac defect occluder
Occlutech ASD Occluder by Occlutech GmbH — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac defect occluder.
- Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC. · Class III
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC · Class III
- Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC. · Class III
- Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III
- WATCHMAN FLX™ Pro — Boston Scientific · Class III
- AMPLATZER™ — Aga Medical Corp. · Class III
- Amplatzer™ — Aga Medical Corp. · Class III
- Amplatzer™ — Aga Medical Corp. · Class III
Cleared under the same submission
P200032 also covers:
- Occlutech Pistol Pusher — OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
- Occlutech Pistol Pusher — OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
- Occlutech Pistol Pusher — OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
- Occlutech Pistol Pusher — OCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
- Occlutech ASD Occluder — Occlutech GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Occlutech GmbH
Sources (1)
- FDA UDI 2159213e-5c73-4012-a072-5943ccc44cae 38 fields · synced May 30, 2026