Cleared Traditional

RIVAL PTA DILATATION CATHETER

K120722 · Bard Peripheral Vascular, Inc. · Cardiovascular
Apr 2012
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K120722 is an FDA 510(k) clearance for the RIVAL PTA 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 April 19, 2012, 41 days after receiving the submission on March 9, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K120722 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 2012
Decision Date April 19, 2012
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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