Cleared Traditional

K810124 - SWAN-GANZ VIP THERMODILUTION CATHETER

K810124 is the FDA 510(k) clearance for SWAN-GANZ VIP THERMODILUTION CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K810124 · American Edwards Laboratories · Cardiovascular device
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Feb 1981
Decision
16d
Days
Class 2
Risk

K810124 is an FDA 510(k) clearance for the SWAN-GANZ VIP THERMODILUTION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 4, 1981 after a review of 16 days - a notably fast clearance cycle.

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: 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 American Edwards Laboratories devices

Submission Details

510(k) Number K810124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1981
Decision Date February 04, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K810124.
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · Sorensen Research · Sep 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · American Edwards Laboratories · Sep 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · American Edwards Laboratories · Mar 1981
TORQUE CONTROL BALLOON CATHETER
K802338 · Cordis Corp. · Oct 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · Cordis Corp. · Aug 1980
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · C.R. Bard, Inc. · Dec 1978