Cleared Traditional

Fogarty Arterial Embolectomy Catheter with Gate Valve

K233820 · Edwards Lifesciences · Cardiovascular
May 2024
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K233820 is an FDA 510(k) clearance for the Fogarty Arterial Embolectomy Catheter with Gate Valve, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on May 22, 2024, 173 days after receiving the submission on December 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K233820 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2023
Decision Date May 22, 2024
Days to Decision 173 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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