Product code OZG
- Device name
- Transcatheter Septal Occluder (Atrial)
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P200032S005 | Occlutech Pistol Pusher | Occlutech Holding AG | 2026-05-11 |
| P200032S004 | Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack | Occlutech Holding AG | 2025-12-18 |
| P200032S003 | Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack | Occlutech Holding AG | 2025-11-24 |
| P200032S002 | Occlutech® ASD Occluder and Occlutech® Pistol Pusher | Occlutech Holding AG | 2025-04-18 |
| P200032S001 | Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack | Occlutech Holding AG | 2024-06-07 |
| P200032 | Occlutech® ASD Occluder and Occlutech® Pistol Pusher | Occlutech Holding AG | 2023-12-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07340175601941 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602085 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602078 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602061 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602054 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602047 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602030 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602023 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602016 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175602009 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175601996 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175601989 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175601972 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175601965 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 07340175601958 | Occlutech ASD Occluder Procedure Pack | Occlutech International AB | 2024-03-05 |
| 04260182521540 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521687 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521670 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521663 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521656 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521649 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521632 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521625 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521618 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521601 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521595 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521588 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521571 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521564 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |
| 04260182521557 | Occlutech ASD Occluder | Occlutech GmbH | 2024-03-05 |