Cleared Traditional

K810352 - SWAN-GANZ FLOW-DIRECTED THERMODILUTION

K810352 is an FDA 510(k) clearance for SWAN-GANZ FLOW-DIRECTED THERMODILUTION, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K810352 · American Edwards Laboratories · Cardiovascular device
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Mar 1981
Decision
45d
Days
Class 2
Risk

K810352 is an FDA 510(k) clearance for the SWAN-GANZ FLOW-DIRECTED THERMODILUTION. 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 March 27, 1981 after a review of 45 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

FDA 510(k) Submission Details - K810352

510(k) Number K810352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1981
Decision Date March 27, 1981
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
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 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K810352.
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · Norton Performance Plastics Corp. · Feb 1982
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · Sorensen Research · Sep 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · American Edwards Laboratories · Sep 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · American Edwards Laboratories · Feb 1981
SWAN GANZ CATHETER PLACEMENT KIT
K802288 · Stanco Medical, Inc. · Nov 1980
TORQUE CONTROL BALLOON CATHETER
K802338 · Cordis Corp. · Oct 1980