Cleared Traditional

ValvuloPro Valvuloplasty Balloon Catheter

K231814 · Dongguan TT Medical, Inc. · Cardiovascular

Oct 2023

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K231814 is an FDA 510(k) clearance for the ValvuloPro Valvuloplasty Balloon Catheter, a Balloon Aortic Valvuloplasty (Class II — Special Controls, product code OZT), submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on October 12, 2023, 113 days after receiving the submission on June 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1255.

Submission Details

510(k) Number	K231814 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2023
Decision Date	October 12, 2023
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OZT — Balloon Aortic Valvuloplasty
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1255
Definition	A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.