Cleared Special

K260437 - Valvuloplasty Balloon Catheter (ValvuloPro)

K260437 is an FDA 510(k) clearance for Valvuloplasty Balloon Catheter (ValvuloPro), 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 37-day FDA review.

K260437 · Dongguan TT Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
37d
Days
Class 2
Risk

K260437 is an FDA 510(k) clearance for the Valvuloplasty Balloon Catheter (ValvuloPro). 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 March 20, 2026 after a review of 37 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K260437

510(k) Number K260437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2026
Decision Date March 20, 2026
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 K260437.
KardiaPSI Balloon Catheter
K253855 · Intervention Tech, Inc. ; dba Corvention · May 2026
OutFlo Aortic Valve Dilatation Balloon Catheter
K241562 · Disa Medinotec · Mar 2025
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · Dongguan TT Medical, Inc. · Jul 2024
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
K260437 · Valvuloplasty Balloon Catheter (ValvuloPro)
Download PDF FDA Summary Dongguan TT Medical, …