Cleared Traditional

K812563 - SWAN-GANZ & EDSLAB HEPARIN COATED CATH.

K812563 is an FDA 510(k) clearance for SWAN-GANZ & EDSLAB HEPARIN COATED CATH., 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 17-day FDA review.

K812563 · American Edwards Laboratories · Cardiovascular device
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Sep 1981
Decision
17d
Days
Class 2
Risk

K812563 is an FDA 510(k) clearance for the SWAN-GANZ & EDSLAB HEPARIN COATED CATH.. 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 September 25, 1981 after a review of 17 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 - K812563

510(k) Number K812563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1981
Decision Date September 25, 1981
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K812563.
SWAN-GANZ VIP-CATHETER
K820222 · American Edwards Laboratories · Feb 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · Norton Performance Plastics Corp. · Feb 1982
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · Sorensen Research · Sep 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · American Edwards Laboratories · Mar 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · American Edwards Laboratories · Feb 1981
SWAN GANZ CATHETER PLACEMENT KIT
K802288 · Stanco Medical, Inc. · Nov 1980