Cleared Traditional

K211610 - Fogarty Occlusion Catheter

K211610 is an FDA 510(k) clearance for Fogarty Occlusion Catheter, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 265-day FDA review.

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

K211610 is an FDA 510(k) clearance for the Fogarty Occlusion Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on February 14, 2022 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K211610

510(k) Number K211610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MJN Catheter, Intravascular Occluding, Temporary

All 77
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K211610.
Bridge Plus Occlusion Balloon (590-002)
K251358 · Philips Image Guided Therapy Devices · Jun 2025
preCARDIA Occlusion System
K221294 · Abiomed, Inc. · Jun 2023
LANDMARK REBOA Catheter
K214060 · Zien Medical Technologies, Inc. · Sep 2022
RenovoCath
K212324 · Renovorx, Inc. · Aug 2021
AortaSTAT Occlusion Device
K210602 · Renalpro Medical, Inc. · Jul 2021
Neurescue device
K210358 · Neurescue Aps · May 2021