Cleared Traditional

Fogarty Occlusion Catheter

K211610 · Edwards Lifesciences, LLC · Cardiovascular
Feb 2022
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K211610 is an FDA 510(k) clearance for the Fogarty Occlusion Catheter, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on February 14, 2022, 265 days after receiving the submission on May 25, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K211610 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2021
Decision Date February 14, 2022
Days to Decision 265 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MJN — Catheter, Intravascular Occluding, Temporary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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