Consulting Wallah › Device Explorer › Cardiovascular › Cardiac defect occluder
Device Explorer · FDA GUDID · GMDN 45418

Cardiac defect occluder

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 material

US‑registered devices177in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Aga Medical Corporation5732%
St. Jude Medical, Inc.5028%
Occlutech Gmbh3017%
Boston Scientific Corporation2212%
W. L. Gore & Associates, Inc.85%
Pfm Medical Ag63%
Occlutech Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi42%

Top labelers

CompanyDevicesShare
Aga Medical Corporation5732%
St. Jude Medical, Inc.5028%
Occlutech Gmbh3017%
Boston Scientific Corporation2212%
W. L. Gore & Associates, Inc.85%
Pfm Medical Ag63%
Occlutech Tibbi Urunler Sanayi Ve Ticaret Limited Sirketi42%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Amplatzer™ Talisman™Amplatzer Piccolo™Amplatzer™AMPLATZER™Occlutech ASD OccluderOcclutech ASD Occluder Procedure PackNit-Occlud PDAAmplatzer™ Amulet™GORE CARDIOFORM ASD OccluderGORE CARDIOFORM Septal OccluderWATCHMAN FLX™ ProWATCHMAN FLX™WATCHMAN®Occlutech Pistol Pusher

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MLVTranscatheter septal occluder72
OZGTranscatheter Septal Occluder (Atrial)49
NGVSystem, appendage closure, left atrial30
MAEOCCLUDER, PATENT DUCTUS, ARTERIOSUS22
MLVTranscatheter Septal Occluder20
MAEOccluder, Patent Ductus, Arteriosus6

GMDN & GCC registration

  • GMDN code 45418 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 171Catheter Gauge (French) · 9Length (Centimeter) · 9Width (Millimeter) · 5Height (Millimeter) · 5

Use these as the dimensions to specify in a tender line.

How many cardiac defect occluder products are registered in the US?

177 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac defect occluder", from 7 companies. The largest labeler is Aga Medical Corporation with 32% of records.

Which FDA product codes apply?

MLV (Transcatheter septal occluder), OZG (Transcatheter Septal Occluder (Atrial)), NGV (System, appendage closure, left atrial), MAE (OCCLUDER, PATENT DUCTUS, ARTERIOSUS)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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