Cleared Traditional

SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER

K133843 · Cordis Corporation · Cardiovascular
Jun 2014
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K133843 is an FDA 510(k) clearance for the SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Corporation (Fremont, US). The FDA issued a Cleared decision on June 27, 2014, 191 days after receiving the submission on December 18, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K133843 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2013
Decision Date June 27, 2014
Days to Decision 191 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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