Cleared Traditional

ULTRAVERSE RX PTA BALLOON DILATATION CATHETER

K131199 · Bard Peripheral Vascular, Inc. · Cardiovascular
May 2013
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K131199 is an FDA 510(k) clearance for the ULTRAVERSE RX PTA BALLOON DILATATION CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 30, 2013, 34 days after receiving the submission on April 26, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K131199 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2013
Decision Date May 30, 2013
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

Similar Devices — LIT Catheter, Angioplasty, Peripheral, Transluminal

All 401
Armada? 14 NC PTA Catheter
K252512 · Abbott Medical · Feb 2026
Amethyst HP PTA OTW 0.035 Catheter
K251915 · Natec Medical , Ltd. · Dec 2025
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
K250706 · Biotronik, Inc. · Apr 2025
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
K243704 · Brosmed Medical Co., Ltd. · Feb 2025
Amethyst HP PTA OTW 0.035 Catheter
K241040 · Natec Medical , Ltd. · Dec 2024
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K242419 · Creagh Medical Ltd. Dba Surmodics, Inc. · Nov 2024