Cleared Special

Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

K211875 · William Cook Europe Aps · Cardiovascular
Jul 2021
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K211875 is an FDA 510(k) clearance for the Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on July 28, 2021, 41 days after receiving the submission on June 17, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K211875 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2021
Decision Date July 28, 2021
Days to Decision 41 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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