Cleared Traditional

OCCLUSION BALLOON CATHETER, MODEL VENOS

K081052 · Oscor, Inc. · Cardiovascular
Jun 2008
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K081052 is an FDA 510(k) clearance for the OCCLUSION BALLOON CATHETER, MODEL VENOS, a Catheter, Flow Directed (Class II — Special Controls, product code DYG), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 18, 2008, 65 days after receiving the submission on April 14, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1240.

Submission Details

510(k) Number K081052 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2008
Decision Date June 18, 2008
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DYG — Catheter, Flow Directed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1240

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