Cleared Special

K260437 - Valvuloplasty Balloon Catheter (ValvuloPro) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260437 · Dongguan TT Medical, Inc. · Cardiovascular device
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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.

View all Dongguan TT Medical, Inc. devices

Submission Details

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.

Device Classification

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.