Consulting Wallah › Device Explorer › Cardiovascular › Cardiac occluder delivery kit
Device Explorer · FDA GUDID · GMDN 45419

Cardiac occluder delivery kit

A collection of devices designed to implant a cardiac occluder (not included) for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravas

US‑registered devices123in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Lifetech Scientific (Shenzhen) Co., Ltd.7259%
Aga Medical Corporation2520%
St. Jude Medical, Inc.2016%
Boston Scientific Corporation65%

Top labelers

CompanyDevicesShare
Lifetech Scientific (Shenzhen) Co., Ltd.7259%
Aga Medical Corporation2520%
St. Jude Medical, Inc.2016%
Boston Scientific Corporation65%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FuStarTM Steerable introducerAmplatzer Piccolo™Amulet™Amplatzer™ Talisman™Amplatzer™ Trevisio™Amplatzer™ TorqVue™ 45° x 45°AMPLATZER™Amplatzer™ TorqVue™WATCHMAN TruSteer™ Access SystemWATCHMAN FXD Curve™ Access SystemWATCHMAN® Access System

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

FDA product codes

CodeNameDevices
DQYCatheter, Percutaneous72
DQYCATHETER, PERCUTANEOUS33
DQYCatheter, percutaneous19
NGVSystem, appendage closure, left atrial3

GMDN & GCC registration

  • GMDN code 45419 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 99% · 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

Catheter Gauge (French) · 45Length (Centimeter) · 22Outer Diameter (Millimeter) · 6Lumen/Inner Diameter (Millimeter) · 6

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

How many cardiac occluder delivery kit products are registered in the US?

123 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac occluder delivery kit", from 4 companies. The largest labeler is Lifetech Scientific (Shenzhen) Co., Ltd. with 59% of records.

Which FDA product codes apply?

DQY (Catheter, Percutaneous), DQY (CATHETER, PERCUTANEOUS), DQY (Catheter, percutaneous), NGV (System, appendage closure, left atrial)

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.

How do I get quotes?

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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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