FDA.reportPublic FDA data

Cardiac defect occluder

Definition
An 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.
GUDID devices
56
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00191506040147WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC602002023-09-12
00191506040154WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC602402023-09-12
00191506040161WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC602702023-09-12
00191506040178WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC603102023-09-12
00191506040185WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC603502023-09-12
00191506040192WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WC604002023-09-12
00733132606979GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.HX20152017-02-13
00733132606986GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.HX20202017-02-13
00733132606993GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.HX20252017-02-13
00733132607006GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.HX20302017-02-13
00733132607013GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.HX20352017-02-13
04042301159953Nit-Occlud PDApfm medical ag145054V22014-08-06
04042301159977Nit-Occlud PDApfm medical ag145065V22014-08-06
04042301159991Nit-Occlud PDApfm medical ag145076V22014-08-06
04042301160010Nit-Occlud PDApfm medical ag145096V22014-08-06
04042301160034Nit-Occlud PDApfm medical ag145116V22014-08-06
00191506004583WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU602002023-09-12
00191506004590WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU602402023-09-12
00191506004606WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU602702023-09-12
00191506004613WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU603102023-09-12
00191506004620WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU603502023-09-12
00191506004637WATCHMAN FLX™ ProBOSTON SCIENTIFIC CORPORATIONM635WU604002023-09-12
04260182521540Occlutech ASD OccluderOcclutech GmbH37ASD062024-03-05
04260182521557Occlutech ASD OccluderOcclutech GmbH37ASD072024-03-05
04260182521564Occlutech ASD OccluderOcclutech GmbH37ASD092024-03-05
04260182521571Occlutech ASD OccluderOcclutech GmbH37ASD102024-03-05
04260182521588Occlutech ASD OccluderOcclutech GmbH37ASD122024-03-05
04260182521595Occlutech ASD OccluderOcclutech GmbH37ASD132024-03-05
04260182521601Occlutech ASD OccluderOcclutech GmbH37ASD152024-03-05
04260182521618Occlutech ASD OccluderOcclutech GmbH37ASD162024-03-05
04260182521625Occlutech ASD OccluderOcclutech GmbH37ASD182024-03-05
04260182521632Occlutech ASD OccluderOcclutech GmbH37ASD192024-03-05
04260182521649Occlutech ASD OccluderOcclutech GmbH37ASD212024-03-05
04260182521656Occlutech ASD OccluderOcclutech GmbH37ASD242024-03-05
04260182521663Occlutech ASD OccluderOcclutech GmbH37ASD272024-03-05
04260182521670Occlutech ASD OccluderOcclutech GmbH37ASD302024-03-05
04260182521687Occlutech ASD OccluderOcclutech GmbH37ASD332024-03-05
07340175601941Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD06P2024-03-05
07340175601958Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD07P2024-03-05
07340175601965Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD09P2024-03-05
07340175601972Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD10P2024-03-05
07340175601989Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD12P2024-03-05
07340175601996Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD13P2024-03-05
07340175602009Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD15P2024-03-05
07340175602016Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD16P2024-03-05
07340175602023Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD18P2024-03-05
07340175602030Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD19P2024-03-05
07340175602047Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD21P2024-03-05
07340175602054Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD24P2024-03-05
07340175602061Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD27P2024-03-05
07340175602078Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD30P2024-03-05
07340175602085Occlutech ASD Occluder Procedure PackOcclutech International AB37ASD33P2024-03-05
08683463400161Occlutech Pistol PusherOCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI38PP1252024-03-05
08683463400185Occlutech Pistol PusherOCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI38PP1652024-03-05
08683463400208Occlutech Pistol PusherOCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI38PP1852024-03-05
08683463400222Occlutech Pistol PusherOCCLUTECH TIBBI URUNLER SANAYI VE TICARET LIMITED SIRKETI38PP2102024-03-05