Cleared Traditional

K822723 - SWAN-GANZ BIPOLAR PACING CATHETER

K822723 is the FDA 510(k) clearance for SWAN-GANZ BIPOLAR PACING CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K822723 · American Edwards Laboratories · Cardiovascular device
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Oct 1982
Decision
38d
Days
Class 2
Risk

K822723 is an FDA 510(k) clearance for the SWAN-GANZ BIPOLAR PACING 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 October 15, 1982 after a review of 38 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 K822723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 15, 1982
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K822723.
CARDIAC OUTPUT MEASURE SYSTEM
K831185 · Cook, Inc. · May 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · Critikon Company, LLC · Nov 1982
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350 · American Edwards Laboratories · Aug 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · Norton Performance Plastics Corp. · Jul 1982
MEDTRONIC S3 TM SYSTEM
K821004 · Medtronic Vascular · May 1982