Cleared Traditional

K803058 - SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K803058 · American Edwards Laboratories · Cardiovascular device
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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
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 127
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