Cleared Traditional

CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F

K034050 · Cordis Corporation · Cardiovascular
Mar 2004
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K034050 is an FDA 510(k) clearance for the CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Cordis Corporation (Warren, US). The FDA issued a Cleared decision on March 22, 2004, 83 days after receiving the submission on December 30, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K034050 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2003
Decision Date March 22, 2004
Days to Decision 83 days
Submission Type Traditional
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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