Cleared Special

K240967 - ValvuloPro Valvuloplasty Balloon Catheter

K240967 is an FDA 510(k) clearance for ValvuloPro Valvuloplasty Balloon Catheter, manufactured by Dongguan TT Medical, Inc.. The device is a Class 2 Cardiovascular device with product code OZT cleared through the Special 510(k) pathway after a 113-day FDA review.

K240967 · Dongguan TT Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
113d
Days
Class 2
Risk

K240967 is an FDA 510(k) clearance for the ValvuloPro Valvuloplasty Balloon Catheter. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on July 31, 2024 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1255 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K240967

510(k) Number K240967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2024
Decision Date July 31, 2024
Days to Decision 113 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

OZT Device Classification - Class 2, Special Controls

Product Code OZT Balloon Aortic Valvuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1255
Definition A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OZT Balloon Aortic Valvuloplasty

All 21
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K240967.
KardiaPSI Balloon Catheter
K253855 · Intervention Tech, Inc. ; dba Corvention · May 2026
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437 · Dongguan TT Medical, Inc. · Mar 2026
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562 · Disa Medinotec · Mar 2025
ValvuloPro Valvuloplasty Balloon Catheter
K231814 · Dongguan TT Medical, Inc. · Oct 2023
INOUE BALLOON A
K220881 · Toray Industries, Inc. · Dec 2022
True Flow Valvuloplasty Perfusion Catheter
K172932 · C.R. Bard, Inc. · Dec 2017
K240967 · ValvuloPro Valvuloplasty Balloon Catheter
Download PDF FDA Summary Dongguan TT Medical, …