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FDA 510(k)

Valvuloplasty Balloon Catheter (ValvuloPro)

K-Number: K260437 · 2026-03-20

ApplicantDongguan TT Medical, Inc.
Decision Date2026-03-20
Product CodeOZT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Dongguan TT Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240967ValvuloPro Valvuloplasty Balloon CatheterK231814ValvuloPro Valvuloplasty Balloon CatheterK230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)K222663MultiStage Balloon Dilatation CatheterK222187Multistage Balloon Dilatation Catheter

Related Devices (Code: OZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253855KardiaPSI Balloon CatheterIntervention Tech, Inc. ; dba CorventionK241562OutFlo Aortic Valve Dilatation Balloon CatheterDisa MedinotecK240967ValvuloPro 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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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