Cleared Traditional

SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME (K896466) - FDA 510(k) Clearance

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

K896466 · Baxter Healthcare Corp · Cardiovascular device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896466 is an FDA 510(k) clearance for the SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on February 8, 1990 after a review of 87 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K896466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1989
Decision Date February 08, 1990
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 29
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K896466.
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · Baxter Healthcare Corp · Oct 1993
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990
BARD CATH LAB THERMODILUTION CATHETER
K893474 · C.R. Bard, Inc. · Sep 1989
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465 · Abbott Laboratories · May 1988
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · Medtronic Vascular · Nov 1987