Cleared Traditional

Ultraverse 035 PTA Balloon Dilatation Catheter

K142261 · Bard Peripheral Vascular, Inc. · Cardiovascular
Sep 2014
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K142261 is an FDA 510(k) clearance for the Ultraverse 035 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 September 24, 2014, 41 days after receiving the submission on August 14, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K142261 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2014
Decision Date September 24, 2014
Days to Decision 41 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

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