Cleared Traditional

Coronary Dilatation Balloon Catheter (VesPenetrator?), Coronary Dilatation Balloon Catheter (VesTraveler?), Coronary Dilatation Balloon Catheter (VexPander?)

K230374 · Dongguan TT Medical, Inc. · Cardiovascular

Jun 2023

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K230374 is an FDA 510(k) clearance for the Coronary Dilatation Balloon Catheter (VesPenetrator?), Coronary Dilatation Balloon Catheter (VesTraveler?), Coronary Dilatation Balloon Catheter (VexPander?), a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Dongguan TT Medical, Inc. (Dongguan, CN). The FDA issued a Cleared decision on June 29, 2023, 136 days after receiving the submission on February 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.

Submission Details

510(k) Number	K230374 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2023
Decision Date	June 29, 2023
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5100
Definition	A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.