Cleared Traditional

K233619 - Fogarty Corkscrew Catheters

Also marketed or referenced as:
Fogarty Graft Thrombectomy Catheters

K233619 is an FDA 510(k) clearance for Fogarty Corkscrew Catheters, manufactured by Edwards Lifesciences. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K233619 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
189d
Days
Class 2
Risk

K233619 is an FDA 510(k) clearance for the Fogarty Corkscrew Catheters. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on May 20, 2024 after a review of 189 days - an extended review 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: 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 devices

FDA 510(k) Submission Details - K233619

510(k) Number K233619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date May 20, 2024
Days to Decision 189 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
64d slower than avg
Panel avg: 125d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K233619.
Fogarty Fortis Arterial Embolectomy Catheter
K241330 · Edwards Lifesciences · Jul 2024
Fogarty Venous Thrombectomy Catheters
K233819 · Edwards Lifesciences, LLC · May 2024
Fogarty Arterial Embolectomy Catheter with Gate Valve
K233820 · Edwards Lifesciences · May 2024
Merlin Aspiration System
K213771 · Mivi Neurovascular, Inc. · Jan 2022
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
K202049 · Applied Medical Resources Corporation · Sep 2021
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
K193379 · Edwards Lifesciences, LLC · Jun 2020