Cleared Special

Denali? Vena Cava Filter System ? Femoral and Jugular/Subclavian Delivery Kit

K240257 · Bd · Cardiovascular
Feb 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240257 is an FDA 510(k) clearance for the Denali? Vena Cava Filter System ? Femoral and Jugular/Subclavian Delivery Kit, a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Bd (Tempe, US). The FDA issued a Cleared decision on February 29, 2024, 29 days after receiving the submission on January 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K240257 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2024
Decision Date February 29, 2024
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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