Cleared Traditional

K951566 - SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]

K951566 is an FDA 510(k) clearance for SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OX..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K951566 · Baxter Healthcare Corp · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 1995
Decision
237d
Days
Class 2
Risk

K951566 is an FDA 510(k) clearance for the SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION F.... 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 November 27, 1995 after a review of 237 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K951566

510(k) Number K951566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date November 27, 1995
Days to Decision 237 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 125d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K951566.
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · Baxter Healthcare Corp · May 1997
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
K963248 · J-Lloyd Medical, Inc. · Feb 1997
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · Boston Scientific Scimed, Inc. · Nov 1996
FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
K940547 · J-Lloyd Medical, Inc. · Aug 1994
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K935404 · J-Lloyd Medical, Inc. · May 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994