Cleared Traditional

K231248 - Swan-Ganz Catheters

K231248 is an FDA 510(k) clearance for Swan-Ganz Catheters, manufactured by Edwards Lifesciencess, LLC. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K231248 · Edwards Lifesciencess, LLC · Cardiovascular device
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Sep 2023
Decision
143d
Days
Class 2
Risk

K231248 is an FDA 510(k) clearance for the Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Adv.... Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Edwards Lifesciencess, LLC (Irvine, US). The FDA issued a Cleared decision on September 21, 2023 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Lifesciencess, LLC devices

FDA 510(k) Submission Details - K231248

510(k) Number K231248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2023
Decision Date September 21, 2023
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 57
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K231248.
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
K242451 · Edwards Lifesciences · Dec 2024
Swan-Ganz Pacing Probe and Catheters
K233983 · Edwards Lifesciences · Jun 2024
Swan-Ganz catheter
K233824 · Edwards Lifesciences, LLC · Jun 2024
Swang-Ganz IQ pulmonary artery catheter
K222117 · Edwards Lifesiences, LLC · Dec 2022
Swan-Ganz Catheters
K193466 · Edwards Lifesciences, LLC · Feb 2020
Swan Ganz Catheters
K160084 · Edwards Lifesciences, LLC · May 2016