Cleared Traditional

K241330 - Fogarty Fortis Arterial Embolectomy Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241330 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
53d
Days
Class 2
Risk

K241330 is an FDA 510(k) clearance for the Fogarty Fortis Arterial Embolectomy Catheter. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on July 2, 2024 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Lifesciences devices

Submission Details

510(k) Number K241330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date July 02, 2024
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 73
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K241330.
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Merlin Aspiration System
K213771 · Mivi Neurovascular, Inc. · Jan 2022
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
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