Cleared Special

CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B

K023116 · Cordis Corp. · Cardiovascular
Oct 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K023116 is an FDA 510(k) clearance for the CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on October 18, 2002, 29 days after receiving the submission on September 19, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K023116 FDA.gov
FDA Decision Cleared SESU
Date Received September 19, 2002
Decision Date October 18, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTK — Filter, Intravascular, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3375

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