FDA 510(k)

Valvuloplasty Balloon Catheter (ValvuloPro)

Número K: K260437 · 2026-03-20

Data da decisão2026-03-20

Código do produtoOZT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Valvuloplasty Balloon Catheter (ValvuloPro) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan TT Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K260437. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Valvuloplasty Balloon Catheter (ValvuloPro)?

Valvuloplasty Balloon Catheter (ValvuloPro) is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Dongguan TT Medical, Inc.. The 510(k) number is K260437.

When did Valvuloplasty Balloon Catheter (ValvuloPro) receive FDA 510(k) clearance?

Valvuloplasty Balloon Catheter (ValvuloPro) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K260437.

Who is the listed applicant for Valvuloplasty Balloon Catheter (ValvuloPro)?

The FDA 510(k) record lists Dongguan TT Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Valvuloplasty Balloon Catheter (ValvuloPro)?

The FDA product code for Valvuloplasty Balloon Catheter (ValvuloPro) is OZT.

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Outros registros que listam Dongguan TT Medical, Inc. como candidato(a)

K240967ValvuloPro Valvuloplasty Balloon Catheter K231814ValvuloPro Valvuloplasty Balloon Catheter K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)K222663MultiStage Balloon Dilatation Catheter K222187Multistage Balloon Dilatation Catheter

Dispositivos Relacionados (Código: OZT)

K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba Corvention K241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa Medinotec K240967ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K231814ValvuloPro Valvuloplasty Balloon CatheterDongguan TT Medical, Inc.K220881INOUE BALLOON AToray Industries, Inc.K172932True Flow Valvuloplasty Perfusion CatheterC.R. Bard, Inc.

Fonte oficial

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