Cleared Traditional

SWAN-GANZ HEPARIN COATED, ETC. CATHETER (K811411) - FDA 510(k) Clearance

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

K811411 · American Edwards Laboratories · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
24d
Days
Class 2
Risk

K811411 is an FDA 510(k) clearance for the SWAN-GANZ HEPARIN COATED, ETC. CATHETER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 K811411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1981
Decision Date June 12, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 36
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K811411.
PiCCO Catheter
K171620 · Pulsion Medical Systems SE · Feb 2018
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · C.R. Bard, Inc. · Nov 1979
CATHETER, THERMAL DILUTION, ANIMAL & PED
K760064 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, PEDIATRIC
K760065 · Instrumentation Laboratory CO · Jul 1976
CATHETER, THERMAL DILUTION, OPEN CHEST
K760067 · Instrumentation Laboratory CO · Jul 1976