Cleared Traditional

K160084 - Swan Ganz Catheters

K160084 is an FDA 510(k) clearance for Swan Ganz Catheters, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K160084 · Edwards Lifesciences, LLC · Cardiovascular device
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May 2016
Decision
109d
Days
Class 2
Risk

K160084 is an FDA 510(k) clearance for the Swan Ganz Catheters. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on May 3, 2016 after a review of 109 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 Lifesciences, LLC devices

FDA 510(k) Submission Details - K160084

510(k) Number K160084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2016
Decision Date May 03, 2016
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 K160084.
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
K231248 · Edwards Lifesciencess, LLC · Sep 2023
Swang-Ganz IQ pulmonary artery catheter
K222117 · Edwards Lifesiences, LLC · Dec 2022
Swan-Ganz Catheters
K193466 · Edwards Lifesciences, LLC · Feb 2020
OCCLUSION BALLOON CATHETER, MODEL VENOS
K081052 · Oscor, Inc. · Jun 2008
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · Medtronic Vascular · Aug 2001
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp · Jul 2000