Cleared Traditional

K803058 - SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.

K803058 is the FDA 510(k) clearance for SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K803058 · American Edwards Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
45d
Days
Class 2
Risk

K803058 is an FDA 510(k) clearance for the SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 16, 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 870.3680 - 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 K803058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1980
Decision Date January 16, 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.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 75
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K803058.
TEMPTRON #'S 6804/6805
K810657 · Medtronic Vascular · Apr 1981
ELECATH DUAL MODE TRANSTHORACIC PACING
K810312 · Electro-Catheter Corp. · Mar 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980
SWAN-GANZ FLOW-DIRECTED CATHETER
K791183 · Edwards Lifesciences, LLC · Jul 1979
TEMPORARY CARDIAC PACING WIRE
K781002 · Ethicon, Inc. · Dec 1978