Cleared Traditional

Fogarty Thru-Lumen Embolectomy Catheter

K240078 · Edwards Lifesciences, LLC · Cardiovascular
Aug 2024
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K240078 is an FDA 510(k) clearance for the Fogarty Thru-Lumen Embolectomy Catheter, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 28, 2024, 230 days after receiving the submission on January 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K240078 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2024
Decision Date August 28, 2024
Days to Decision 230 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXE — Catheter, Embolectomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150

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