Cleared Traditional

K193379 - Fogarty Arterial Embolectomy Catheter

K193379 is an FDA 510(k) clearance for Fogarty Arterial Embolectomy Catheter, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K193379 · Edwards Lifesciences, LLC · Cardiovascular device
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Jun 2020
Decision
190d
Days
Class 2
Risk

K193379 is an FDA 510(k) clearance for the Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 12, 2020 after a review of 190 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, LLC devices

FDA 510(k) Submission Details - K193379

510(k) Number K193379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date June 12, 2020
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 K193379.
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