Cleared Traditional

ANGIOGRAPHIC CATHETER, MODEL ANGIOS

K092118 · Oscor, Inc. · Cardiovascular
Jan 2010
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K092118 is an FDA 510(k) clearance for the ANGIOGRAPHIC CATHETER, MODEL ANGIOS, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 13, 2010, 183 days after receiving the submission on July 14, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K092118 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2009
Decision Date January 13, 2010
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1200

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