Cleared Traditional

CONQUEST 40 PTA DILATATION CATHETER

K120660 · Bard Peripheral Vascular, Inc. · Cardiovascular
Mar 2012
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K120660 is an FDA 510(k) clearance for the CONQUEST 40 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 March 15, 2012, 10 days after receiving the submission on March 5, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K120660 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2012
Decision Date March 15, 2012
Days to Decision 10 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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