Consulting Wallah › Device Explorer › Catheters & tubes › Cardiac valvuloplasty catheter
Device Explorer · FDA GUDID · GMDN 17453

Cardiac valvuloplasty catheter

A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of

US‑registered devices636in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription98%Rx‑only share
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Share of device records

B Braun Interventional Systems, Inc52983%
Bard Peripheral Vascular, Inc.488%
Edwards Lifesciences Llc213%
Toray Industries,Inc.152%
Intervention Tech, Inc. Dba Corvention112%
Dongguan Tt Medical, Inc.61%
Disa Medinotec (Pty) Ltd51%
Pi-Cardia Ltd10%

Top labelers

CompanyDevicesShare
B Braun Interventional Systems, Inc52983%
Bard Peripheral Vascular, Inc.488%
Edwards Lifesciences Llc213%
Toray Industries,Inc.152%
Intervention Tech, Inc. Dba Corvention112%
Dongguan Tt Medical, Inc.61%
Disa Medinotec (Pty) Ltd51%
Pi-Cardia Ltd10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ShortCutValvuloPro®OutFlo Aortic Valve Valvuloplasty Dilatation BalTYSHAK NuCLEUS™Z-MED™NuCLEUS-X™TYSHAK Mini®TYSHAK II®Z-MED II™COEfficient™TYSHAK®Z-MED II X™Z-MED X™TYSHAK X™VIDA®TRUE FLOW

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

FDA product codes

CodeNameDevices
LITCatheter, angioplasty, peripheral, transluminal445
DQYCATHETER, PERCUTANEOUS395
OZTBalloon aortic valvuloplasty260
MADCATHETER, PERCUTANEOUS (VALVULOPLASTY)54
OZTBalloon Aortic Valvuloplasty46
OMZPulmonary (pulmonic) valvuloplasty catheters/percutaneous va20

GMDN & GCC registration

  • GMDN code 17453 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 98% · 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

Balloon Diameter (Millimeter) · 16Length (Centimeter) · 15Catheter Gauge (French) · 15

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

How many cardiac valvuloplasty catheter products are registered in the US?

636 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cardiac valvuloplasty catheter", from 8 companies. The largest labeler is B Braun Interventional Systems, Inc with 83% of records.

Which FDA product codes apply?

LIT (Catheter, angioplasty, peripheral, transluminal), DQY (CATHETER, PERCUTANEOUS), OZT (Balloon aortic valvuloplasty), MAD (CATHETER, PERCUTANEOUS (VALVULOPLASTY))

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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